Drug Information Update...being recalled. The recalled products contain an impurity,...

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Drug Information Update August 2018

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TABLE OF CONTENTS

NEWLY AVAILABLE GENERICS ................................................................................ 2

NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS .............................................. 3

NEW INDICATIONS (EXISTING DRUGS) ................................................................... 6

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS ............................................. 8

STUDIES AND RECENT TOPICS .............................................................................. 18

RECALLS ............................................................................................................... 25

CURRENT DRUG SHORTAGES ............................................................................... 62

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NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH &

DOSAGE FORM GENERIC

MANUFACTURER BRAND NAME

LIDOCAINE/ EMOLLIENT CMB NO.102

5% PURETEK DERMACINRX PHN PAK

DORZOLAMIDE/TIMOLOL/PF 2%-0.5% AUROBINDO COSOPT PF

BENDAMUSTINE HCL 25MG/ML EAGLE BENDEKA

CLINDAMYCIN PHOS/ BENZOYL PEROX

1.2%-2.5% OCEANSIDE ACANYA

CLINDAMYCIN PHOSPHATE 1% OCEANSIDE CLINDAGEL

DESOXIMETASONE 0.25% TARO PHARM TOPICORT

DEXAMETHASONE 1.5MG (51 TABS) LARKEN LABS DEXPAK

DEXAMETHASONE 1.5MG (35 TABS) LARKEN LABS DEXPAK

LULICONAZOLE 1% OCEANSIDE LUZU

SUCCINYLCHOLINE CHLORIDE 20MG/ML ZYDUS ANECTINE

TADALAFIL 20 MG MYLAN ADCIRCA

METFORMIN HCL 500MG/5ML INNOVIDA RIOMET

HYDROXYPROGESTERONE CAPROATE

250MG/ML PRASCO MAKENA

CROTAMITON 10% MARNEL EURAX

TEMSIROLIMUS 30MG/3ML ACCORD TORISEL

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NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

ANTINEOPLASTIC SYSTEMIC ENZYME

INHIBITORS KYPROLIS CARFILZOMIB 10 MG New strength

CYSTIC FIBROSIS-CFTR POTENTIATOR-

CORRECTOR COMBIN. ORKAMBI

LUMACAFTOR/ IVACAFTOR

100-125 MG New dosage

form

CYSTIC FIBROSIS-CFTR POTENTIATOR-

CORRECTOR COMBIN. ORKAMBI

LUMACAFTOR/ IVACAFTOR

150-188 MG New dosage form; new strength

LAXATIVES AND CATHARTICS

PLENVU PEG3350/SOD

SUL/NACL/KCL/ASB/C

140-9-5.2 G New strength

ELECTROLYTE DEPLETERS LOKELMA SODIUM

ZIRCONIUM CYCLOSILICATE

5 MG New entity

ELECTROLYTE DEPLETERS LOKELMA SODIUM

ZIRCONIUM CYCLOSILICATE

10 MG New entity

ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR

HUMIRA PEN CROHN-UC-HS

STARTER ADALIMUMAB

80 MG/0.8 ML

New strength

ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR

HUMIRA PEN PSORIASIS-UVEITIS

ADALIMUMAB 80MG-40MG New strength

VIRAL/TUMORIGENIC VACCINES

HEPLISAV-B HEPATITIS B VACCINE/PF

20 MCG/0.5 ML

New dosage form

INFLUENZA VIRUS VACCINES

FLUMIST QUAD 2018-2019

FLU VACC QV LIVE 2018(2-49YRS)/PF

10E6.5-7.5 New entity,

nasal

PHARMACOLOGICAL CHAPERONE

GALAFOLD MIGALASTAT HCL 123 MG New entity

AMYLOIDOSIS AGENTS ONPATTRO PATISIRAN

SODIUM, LIPID COMPLEX

10 MG/ 5 ML New entity

ANTIPSYCHOTIC, D2/5HT ANTAGONIST

PERSERIS RISPERIDONE 90 MG New dosage form; new strength

ANTIPSYCHOTIC, D2/5HT ANTAGONIST

PERSERIS RISPERIDONE 120 MG New dosage form; new

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strength

TOPICAL ANTI-INFLAMMATORY

STEROIDAL SILALITE PAK

TRIAMCINOLONE ACETONIDE/

SILICONES 0.1%

New combination

TOPICAL LOCAL ANESTHETICS

WPR PLUS LIDOCAINE HCL/ME-

SALICYL/MENTH 4%-30%-10%

Regulated as a device

OPTHALMIC SURGICAL AIDS

EDETATE DISODIUM EDETATE

DISODIUM 3% drops

New strength and Dosage

form

ANALGESIC, NON-SALICYLATE AND

BARBITURATE COMBINAT

BUTALBITAL-ACETAMINOPHEN

BUTALBITAL/ACETAMINOPHEN

50MG-300MG

New dosage form

ANTI-INFLAMMATORY, INTERLEUKIN-1 BETA

BLOCKERS ILARIS CANAKINUMAB/PF 150MG/ML

New dosage form

NSAID AND TOPICAL IRRITANT COUNTER-

IRRITANT COMB

NUDROXIPAK DSDR-50

DICLOFEN SOD/CAPSAI/M-

SAL/MENT

50MG-0.025%

Rx and OTC in kit


IRRITANT COMB

NUDROXIPAK DSDR-75

DICLOFEN SOD/CAPSAI/M-

SAL/MENT

75MG-0.025%

Rx and OTC in kit

TOPICAL ANTI-INFLAMMATORY, NSAIDS

DICLOFONO DICLOFENAC

SODIUM 1.6%

New dosage form

PROTECTIVES KELARX DIMET/DIMET

CROSSPOL/T.M.SILIC

New entity

LNRG(GNRH) ANTAGONIST, PITUITARY SUPPRESSANT AGENTS

ORILISSA ELAGOLIX SODIUM 150 MG New entity

LNRG(GNRH) ANTAGONIST, PITUITARY SUPPRESSANT AGENTS

ORILISSA ELAGOLIX SODIUM 200 MG New entity


IRRITANT COMB NUDROXIPAK E-400

ETODOLAC/CAPSAICIN/ME-SAL/MENT

400MG-0.025 Rx and OTC in

kit

INFLUENZA VIRUS VACCINES

FLUCELVAX QUAD 2018-2019

FLU VAC QS 18-19 (4YR UP) CELL

60MCG/0.5ML

New entity

INFLUENZA VIRUS FLUCELVAX QUAD FLU VAC QS 18-19 60MCG/0.5M New entity

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VACCINES 2018-2019 (4YR UP) CEL/PF L

TOPICAL AGENTS, MISCELLANEOUS

NEURAPTINE GABAPENTIN 10% New package

size

ANTINEOPLASTIC-ISOCITRATE

DEHYDROGENASE INHIBITORS

TIBSOVO IVOSIDENIB 250 MG New entity

TOPICAL ANTI-INFLAMMATORY, NSAIDS

FROTEK KETOPROFEN 10 % New package

size

METABOLIC FUNCTION DIAGNOSTICS

MACRELIN MACIMORELIN

ACETATE 0.5MG/ML New entity

BETA-ADRENERGIC BLOCKING AGENTS

KAPSPARGO SPRINKLE

METOPROLOL SUCCINATE

25 MG New dosage

form


KAPSPARGO SPRINKLE


50 MG New dosage

form


KAPSPARGO SPRINKLE


100 MG New dosage

form


KAPSPARGO SPRINKLE


200 MG New dosage

form


IRRITANT COMB NUDROXIPAK N-500

NABUMETONE/CAPSAI/M-SALICY/MEN

500MG-0.025 Rx and OTC in

kit

SELECTIVE SEROTONIN 5-HT2A INVERSE AGONISTS

(SSIA) NUPLAZID

PIMAVANSERIN TARTRATE

10 MG New strength

SELECTIVE SEROTONIN 5-HT2A INVERSE AGONISTS

(SSIA) NUPLAZID

PIMAVANSERIN TARTRATE

34 MG New strength

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NEW INDICATIONS (EXISTING DRUGS)

EYLEA® Aug. 17, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). These data are now included in the updated EYLEA label. Source: Regeneron Pharmaceuticals, Inc. Opdivo® Aug. 17, 2018 Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Source: Bristol-Myers Squibb Company LENVIMA® Aug. 16, 2018 Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). This approval was based on results from REFLECT (Study 304), where LENVIMA demonstrated a proven treatment effect on overall survival (OS) by statistical confirmation of noninferiority, as well as statistically significant superiority and clinically meaningful improvements in progressionfree survival (PFS) and objective response rate (ORR) when compared with sorafenib in patients with previously untreated unresectable HCC. Source: Shionogi & Co., Ltd. KALYDECO® Aug. 15, 2018 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane

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conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data. Source: Vertex Pharmaceuticals Incorporated Kisqali® July 18, 2018 Novartis today announced a new approval for Kisqali® (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the US, and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women. FDA reviewed this supplemental New Drug Application (sNDA) under its Real-Time Oncology Review and Assessment Aid pilot programs and approved the application in less than one month after submission. Source: Novartis XTANDI® July 13, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes XTANDI the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC. XTANDI was first approved by the FDA in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel, and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC. Source: Astellas Pharma Inc.

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FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled

Products

[Posted 07/19/2018] ISSUE: The investigation into valsartan-containing products is ongoing and the following list may change.

We will update this statement as we have more information.

There are currently three voluntary recalls related to the NDMA impurity detected in the valsartan API:

• Teva Pharmaceuticals USA labeled as Major Pharmaceuticals — recall is at the retail level because

these products are only used in facilities where they are directly administered to patients by health care

professionals: Valsartan 80 mg and 160 mg products

• Prinston Pharmaceuticals Inc. labeled as Solco Healthcare LLC — recall is at the consumer/user level:

Valsartan 40 mg, 80 mg, 160 mg, and 320 mg; and valsartan/HCTZ 80 mg/12.5 mg, 160 mg/12.5 mg, 160

mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg products

• Teva Pharmaceuticals labeled as Actavis LLC — recall is at the consumer/user level: Valsartan 40 mg,

80 mg, 160 mg, and 320 mg; and valsartan/HCTZ 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320

mg/12.5 mg, and 320 mg/25 mg products.

BACKGROUND: Valsartan is used to treat high blood pressure and heart failure. Not all products

containing valsartan are being recalled. This update will clarify which valsartan-containing products are

being recalled. The recalled products contain an impurity, N-nitrosodimethylamine (NDMA), in the API

manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China. The presence of the potentially

cancer-causing NDMA was unexpected, and the agency believes the NDMA is related to changes in the

way the active substance was manufactured. Some levels of the impurity may have been in the

valsartan-containing products for as long as four years.

RECOMMENDATION: Patients should be aware that not all valsartan-containing medications are

affected and being recalled and if you have questions, you should ask your pharmacist or health care

provider. Patients should:

• compare the information on your prescription bottle with the information in this list (company,

National Drug Code, lot number) to determine if your current medicine has been recalled.

• continue taking your current medicine until your health care provider or pharmacist gives you a

replacement or a different treatment option.

Health professionals should know:

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• FDA has determined the recalled valsartan products pose an unnecessary risk to patients. Therefore,

FDA recommends patients use valsartan-containing medicines made by other companies or consider

other available treatment options for the patient’s medical condition.

• If you have medication samples from these companies, quarantine the products and do not provide

them to patients.

Health professionals and patients are encouraged to report adverse events or side effects related to the

use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the

address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug

Administration (FDA)

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby

Teething Liquids Due to Microbial Contamination

[Posted 07/20/2018] King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething

liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the

products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas

Fluroescens and Burkholderia Multivorans.

Administration or use of drug products with microbial contamination could potentially result in

increased infections that may require medical intervention, and could result in infections that could be

life threatening to certain individuals. King Bio has not received reports of injury or illness. The Aquaflora

HP9 product is used as a Candida control product. The Lymph Detox product is used for symptoms

associated with lymphatic toxicity. The Baby Teething product is used for symptoms of teething pain,

irritated gums, delayed teething, etc.

King Bio is notifying its distributors and customers by letter and is arranging for return and/or

replacement of all recalled products. Consumers/distributors/retailers that have product which is being

recalled should stop using/and contact King Bio prior to returning the product.

Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail

[email protected], Monday – Friday 830am – 430pm, EST. Consumers should contact their

physician or healthcare provider if they have experienced any problems that may be related to taking or

using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the

FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm

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Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-

1088 to request a reporting form, then complete and return to the address on the pre-addressed form,

or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug Administration (FDA)

FDA updates recalled valsartan-containing product information recall

[Posted 07/27/2018] FDA is updating health care professionals and patients after discovering that several additional

companies that repackage drug products are also recalling valsartan-containing products.

FDA has product recall information from three additional repackagers of valsartan-containing products

made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions

LLC, AvKARE and RemedyRepack – and the agency has added them to the recalled products list. Two of

these companies, A-S Medication and RemedyRepack, may also distribute valsartan products not

affected by the recall. The agency is confirming this information and will provide an update once it is

available.

The following additional repackagers are recalling or are expected to recall valsartan-containing

products. FDA is working to gather product recall information from these companies and has removed

them from the list of products that are not impacted by this recall:

• Bryant Ranch Prepack Inc.

• H. J. Harkins Company Inc. (this company was not originally included on either list)

• Lake Erie Medical, doing business as Quality Care Products LLC

• NuCare Pharmaceuticals Inc.

• Northwind Pharmaceuticals

• Proficient Rx

It is possible that not all valsartan-containing products repackaged by these companies are impacted by

the recall. FDA continues to evaluate valsartan-containing products and will update the list of products

included in the recall and the list of products not included in the recall as more information becomes

available.

Analysis of N-nitrosodimethylamine (NDMA) Levels in Recalled Valsartan in the U.S.

On July 13th, FDA announced a recall of certain batches of valsartan tablets because of an impurity, a

chemical known as N-nitrosodimethylamine (NDMA). Valsartan is a medication commonly used to treat

high blood pressure and heart failure.

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NDMA has been found to increase the occurrence of cancer in animal studies. These animal studies

were done using amounts of NDMA much higher than the impurity levels in recalled valsartan batches.

Based on these animal studies, the U.S. Environmental Protection Agency considers NDMA a probable

human carcinogen—a chemical that can increase the risk of cancer in humans. NDMA is found in some

water supplies and in some foods. Consuming up to 96 nanograms NDMA/day is considered reasonably

safe for human ingestion. It is estimated that over the course of a person’s lifetime, consuming this

amount of NDMA would result in less than one additional case of cancer for every 100,000 people. To

put this in context, currently one out of every three people in the US will experience cancer in their

lifetime.

The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The

agency wanted to put some context around the actual potential risk posed to patients who used

versions of valsartan that may have contained high levels of NDMA. Based on records from the

manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-

containing products for as long as four years. FDA scientists estimate that if 8,000 people took the

highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one

additional case of cancer over the lifetimes of these 8,000 people. This assessment led to FDA’s decision

to have these batches recalled.

Patients taking valsartan from a recalled batch should continue taking their current medicine until their

doctor or pharmacist provides a replacement or a different treatment option. It is important to know

that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of

valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a

different medication that treats the same indications.

FDA continues to evaluate the safety of valsartan-containing products and will update the list of

products included in the recall and the list of products not included in the recall as more information

becomes available. If you are taking a valsartan product, be sure to check to back as the lists may

change. Source: U.S. Food and Drug Administration (FDA)

FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China [Posted 08/17/2018] FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use Sichuan Friendly’s porcine thyroid API received since August 2015. This thyroid API comes from porcine (pig) thyroid glands and is used to make a non-FDA approved drug product, composed of levothyroxine and liothyronine, to treat hypothyroidism (underactive thyroid). FDA laboratory testing confirmed the Sichuan Friendly API has inconsistent levels of the active ingredients – levothyroxine and liothyronine – and should not be used to manufacture or compound

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drugs for patient use. Risks associated with over or under treatment of hypothyroidism could result in permanent or life-threatening adverse health consequences. FDA placed Sichuan Friendly on import import alert 66-40 on March 22, 2018, based on current good manufacturing practice (CGMP) deviations observed during an FDA inspection. However, FDA confirmed Sichuan Friendly’s thyroid API remains in the U.S. supply chain. This API and the drug products made from it, present a safety risk to patients. Sichuan Friendly API may be repackaged and/or relabeled before it is further distributed, and not all of the repackaged/relabeled API identifies Sichuan Friendly as the original API manufacturer. Therefore, manufacturers and compounders who make levothyroxine and liothyronine drug products should contact their API supplier to verify the actual manufacturer of the thyroid API they received before using it. Sichuan Friendly’s products may be labeled as “Thyroid Powder” or “Thyroid Powder USP.” Additionally, manufacturers and compounders who have received API made by Sichuan Friendly should quarantine the API and associated drug products. If manufacturers and compounders have API or drug products made from Sichuan Friendly API, FDA requests these companies contact FDA’s regional offices. FDA recommends patients talk to their health care professional before they stop taking their combination levothyroxine and liothyronine thyroid medicine. FDA also recommends that patients discuss FDA-approved hypothyroidism treatment options with their doctors, as combination levothyroxine and liothyronine products are not FDA-approved. FDA advises patients not to use porcine thyroid medicine labeled as Westminster Additionally, on August 9, 2018, Westminster Pharmaceuticals LLC voluntarily recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets) 15mg, 30mg, 60mg, 90mg, and 120mg. These products were made using API from Sichuan Friendly. FDA laboratory testing confirmed inconsistent levels of levothyroxine and liothyronine. Therefore, FDA recommends patients not use porcine thyroid drug products made by Westminster. FDA inspection and adverse event reporting FDA inspected the Sichuan Friendly’s facility in 2017 and discovered serious quality deficiencies, including: • Use of an incorrect formula to calculate the potency of the API, which means there may be

inconsistent levels of levothyroxine and liothyronine present in the API, and • Multiple batches of API released with certificates of analysis containing inaccurate potency and

stability data, and • No stability data to support the claimed shelf-life of the API. Health care professionals and patients are encouraged to report any adverse events associated with porcine thyroid medications to the FDA’s MedWatch Adverse Event Reporting program: • Complete and submit the report online at www.fda.gov/medwatch/report.htm; or • Download and complete the form, then submit it via fax at 1-800-FDA-0178. FDA will continue to provide additional information as it becomes available. For more information

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• Sichuan Friendly Pharmaceutical Co. Limited warning letter, June 22, 2018 • See Guidance for Industry: ICHQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical

Ingredients for more information on how API, from original manufacturers as well as API repackagers and relabelers, should be labeled and clearly identify the original API manufacturer as the API moves through the supply chain.

Source: U.S. Food and Drug Administration (FDA) UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets [Posted 08/21/2018] Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Product Description Lot/Batch Expiration Date

NDC 13668-325-30 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets

BBX2D025 Nov-2019

NDC 13668- 325-30 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 Tablets

BBX2D026 Nov-2019


BBX2E001 BBX2E002 BBX2E003 BBX2E004 BBX2E005

Jan-2020

NDC 13668- 328-30 Amlodipine, Valsartan and BBX9D004 Nov-2019

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Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 Tablets


BBX9E001 Jan-2020

NDC 13668- 326-30 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 Tablets

BBY1E001 Dec-2019


BBY1E003 Mar-2020


BBY2E001 Mar-2020

NDC 13668- 329-30 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP

5mg/160mg/25mg, 30 Tablets

BBY4D004 Nov-2019



BBY4E001 Jan-2020


BBX2D003 BBX2D004 BBX2D005 BBX2D006 BBX2D007 BBX2D008

Mar-2019


BBX2D015 BBX2D016 BBX2D017 BBX2D018 BBX2D019 BBX2D020 BBX2D021 BBX2D022 BBX2D023

Oct 2019


BBX2D024 Nov 2019


BBX9D001 Feb 2019


BBY1C002 Sept 2018


BBY1E002 Mar-2020

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BBY2D001 Feb 2019


BBY2D002 Nov 2019

NDC 13668- 207-30 Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 Tablets

BV53D004 Oct 2019


BV65D002 Oct 2019


BV77D013 Oct 2019


BV84D010 Oct 2019


BV84E001 Dec 2019


BBX2D001 BBX2D002

Dec 2018


BBX2D009 Mar 2019


BBX2D010 BBX2D011

Apr 2019


BBX2D012 BBX2D013

May 2019


BBX2D014 Aug 2019


BBX9D002 Mar 2019


BBX9D003 Jul 2019


BBY1D001 May 2019



BBY4D001 BBY4D002

Apr 2019



BBY4D003 Jun 2019

NDC 13668- 068-90 Valsartan Tablets, USP, 80 mg, 90 BV46C007 Sept 2018

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Tablets

NDC 13668- 068-90 Valsartan Tablets, USP, 80 mg, 90 Tablets

BV46C008 BV46C009 BV46C010

Oct 2018


BV46C011 BV46C012

Nov 2018

NDC 13668- 069-90 Valsartan Tablets, USP,160 mg, 90 Tablets

BV47C005 BV47C006

Sept 2018


BV47D001 Dec 2018


BV48D002 Dec 2018


BV53C006 Nov 2018


BV53D001 BV53D002

Feb 2019


BV53D003 Sept 2019


BV65C004 Nov 2018


BV65D001 Aug 2019


BV77C001 Oct 2018


BV77D001 BV77D002 BV77D003 BV77D004 BV77D005 BV77D006 BV77D007

Feb 2019


BV77D008 May 2019


BV77D009 Aug 2019


BV77D010 BV77D011 BV77D012

Sept 2019


BV84C011 Oct 2018


BV84D001 BV84D002

Jan 2019


BV84D005 BV84D006 BV84D007

Feb 2019


BV84D008 BV84D009

May 2019

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Valsartan/Amlodipine/HCTZ tablets were distributed Nationwide to Torrent's wholesale, distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their subaccounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter. Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).

[email protected]

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product please contact Qualanex at 1-800- 505-9291 (live calls received 8 am -5:30 pm Eastern Time). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Source: U.S. Food and Drug Administration (FDA)

http://www.fda.gov/medwatch/report.htm

www.performrx.com


STUDIES AND RECENT TOPICS

A pacemaker for depression? New device may help relieve symptoms, study finds August 22, 2018 Thirteen years after the United States Food and Drug Administration approved the use of an implanted nerve stimulator as treatment for antidepressant treatment-resistant individuals with major depression, scientists have found that the pacemaker-like device helped patients reduce depressive symptoms by 50 percent when combined with other common psychiatric treatment. Source: ajc.com Brand-name combo pills may cost more than getting drugs separately August 21, 2018 Brand-name medicines that combine multiple drugs into a single pill may be more expensive than buying each drug separately, a U.S. study suggests. Researchers examined data collected from 2011 to 2016 on 1,500 medicines that accounted for the highest total spending for Medicare Part D drug plans in 2015. This included 29 brand-name combination pills with generic alternatives available. Source: reuters.com Drug Approval Could Boost Research on Marijuana Treatment for Autism August 17, 2018 The United States has approved, for the first time, a compound derived from marijuana to treat certain types of epilepsy. The ruling may spell good news for autism research. The approval of Epidiolex, the new drug, will require a change in the U.S. Drug Enforcement Agency’s classification of marijuana compounds as Schedule 1 drugs—meaning they have no medical use and strong potential for abuse—to something more benign. That decision is expected by 23 September. Source: the‐scientist.com GlaxoSmithKline, Seqirus launch first round of flu shots for upcoming season August 14, 2018 As flu-vaccine heavyweights dispatch their first doses for the upcoming season, they're planning millions more doses made with next-generation production processes rather than traditional egg-based manufacturing. GlaxoSmithKline and Seqirus have joined Sanofi Pasteur in dispatching their first shipments for the coming U.S. flu season. For the latter two, the plans include a significant boost in their cell culture-based vaccines, which are believed to be better than traditional shots made from eggs. Source: fiercepharma.com

www.performrx.com


Poppy seed wash is really a drug, FDA says August 14, 2018 A product called Poppy Seed Wash is advertised as a natural alternative to opioids for relaxation and pain relief, but it’s really just an unlicensed drug, the Food and Drug Administration said Tuesday. The FDA posted a warning letter to the makers of the product, telling them to stop making medical claims and to stop selling it online. Source: nbcnews.com FDA To Consider Midazolam Nasal Spray for Acute Cluster Seizure Treatment August 13, 2018 The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for an investigational nasal spray therapy intended for the acute treatment of seizure clusters. Midazolam Nasal Spray—from global biopharmaceutical company UCB, Brussels, Belgium (UCB)—has been previously granted Orphan Drug and Fast Track designations by the FDA. It’s now set for a potential market approval in early 2019. Source: mdmag.com Rare-Disease Treatment From Alnylam to Cost $450,000 a Year August 10, 2018 Alnylam Pharmaceuticals Inc. won approval from the U.S. Food and Drug Administration for its first-of-a-kind treatment for a rare, often deadly nerve disease and plans to charge about $450,000 a year for the therapy. Patients who have the condition, called hereditary transthyretin-mediated amyloidosis, or hATTR, will take the drug for the rest of their lives, racking up costs in the millions of dollars. After expected discounts in the U.S., Alnylam said it expects the net cost for the drug to be about $345,000 a year. It plans to offer money back if the drug doesn’t work. Source: www.bloomberg.com FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy August 10, 2018 The U.S. Food and Drug Administration today permitted marketing of the first mobile medical application (app) that can be used as a method of contraception to prevent pregnancy. The app, called Natural Cycles, contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older. Source: U.S. Food and Drug Administration (FDA)

www.performrx.com


Trump administration ends Medicaid loophole in drug rebates August 9, 2018 Drug companies will be unable to game a requirement to give states large prescription rebates through Medicaid under a law the Trump administration implemented Thursday. The guidance closes a loophole that drug companies exploited by making superficial changes to existing drugs to inflate their costs and thus pay states less than they owed. The changes allowed drug companies to treat the medicines as new drugs and change the rebate calculation. Source: washingtonexaminer.com FDA broke monthly generic drug approval record in July August 9, 2018 The Food and Drug Administration approved or tentatively approved a record 126 generic drugs in July, the agency reported Thursday, an indication that Republicans are getting the faster approvals they have sought. The agency approved 96 generic drugs and gave a tentative approval to 30 more in July, according to monthly data. Greater generic competition with pricier brand-name drugs is often thought to be a critical factor in improving drug prices. Source: washingtonexaminer.com How pharmacists can help solve medication errors August 9, 2018 In today's health care system, no one person – maybe not even you – knows exactly what drugs you're taking. What's more, no one health care provider knows how you, the patient, take your medications and at what doses. No single, up-to-date record consistently displays all of this important information. The lack of an accurate medication list, and the associated lack of centralized and expert management of your full drug regimen, has serious consequences. Source: medicalxpress.com FDA Approves First Generic Drugs For Fast-Track Review To Combat Overpriced Drugs August 8, 2018 The U.S. Food and Drug Administration approved several products as the first generic drugs to be granted a Competitive Generic Therapy (CGT) designation, which aims to accelerate the development and review processes for generic drugs that lack competition, the FDA announced Wednesday. Source: dailycaller.com

www.performrx.com


U.S. FDA panel backs approval of Paratek's antibiotic August 8, 2018 A U.S. Food and Drug Administration expert panel on Wednesday voted in favor of approval of Paratek Pharmaceuticals Inc’s antibiotic to treat bacterial pneumonia and skin infections. The panel voted 17-1 in favor of the drug’s safety and effectiveness in treating acute bacterial skin and skin structure infections, and voted 14-4 for treating community acquired bacterial pneumonia. Source: reuters.com FDA expands recall of heart drug for possible cancer-causing contamination August 7, 2018 A popular drug used to treat high blood pressure has been recalled because some products may contain a cancer-causing chemical. In an ongoing investigation, the Food & Drug Administration has expanded the swath of the recall of the drug valsartan, which is used to treat high blood pressure and heart failure. The recalled drugs, manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, contain the chemical N-nitrosodimethylamine, or NDMA, which has been found to cause cancer in humans based on laboratory studies, the agency says. Source: usatoday.com FDA to Broaden Evaluation of Opioid Addiction Treatments August 7, 2018 On Monday, officials with the FDA announced that the agency will change the way it evaluates new treatments for opioid addiction, STAT reported. According to the article, the FDA will now consider factors such as whether a drug could reduce overdose rates or transmission of infectious diseases, rather than only examining whether a potential treatment reduces opioid use. In its guidance, the FDA said encouraging drug manufacturers to consider outcomes beyond drug use could yield significant health benefits, the article reported. Source: specialtypharmacytimes.com Fentanyl REMS Effectiveness Unclear, Gets FDA Panel Review August 2, 2018 The FDA will seek information from experts and the public about the effectiveness of its Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines in a public advisory committee meeting Friday. Source: medpagetoday.com

www.performrx.com


FDA: Drug Companies Can’t Game Pediatric Drug Laws Anymore July 26, 2018 Drug companies can’t avoid including kids in certain clinical studies now that the FDA has finally closed a loophole within a pediatric research law. The Food and Drug Administration has been emphasizing the need for kids to be included in drug trials since Scott Gottlieb took over as commissioner of the agency in May 2017. The Pediatric Research Equity Act (PREA), passed in 2003, requires drug companies to study some products in children. Drug companies have been skirting the requirement using certain exemptions. The biggest exemption revolves around so-called orphan drugs that treat small patient populations and rare diseases. Source bna.com Treating Depression May Prevent Repeat Heart Attack July 24, 2018 It's common for heart attack survivors to develop depression. Now a new trial has found that antidepressant treatment may help those patients avoid a second heart attack. The study, of 300 heart patients with depression, found that treatment with the antidepressant escitalopram (Lexapro) almost halved the risk of suffering another heart attack in the next eight years. Source: consumer.healthday.com Troubling questions remain about whether a popular HIV drug causes birth defects July 24, 2018 Dolutegravir, which enjoys a reputation as the best of 32 marketed antiretroviral drugs, took a serious hit in May when a preliminary analysis from a study that included more than 10,000 HIV-infected pregnant women in Botswana revealed it may lead to serious birth defects. Today, at the International AIDS Conference in Amsterdam, researchers reported more data from that study that suggest the risk of harm may be lower than first thought. But troubling questions remain about its safety during pregnancy and whether programs that plan to promote it widely should restrict its use in women of child-bearing age. Source: sciencemag.org CBO underestimates Medicare Part D savings by $4 billion due to oversight lapse July 23, 2018 The Congressional Budget Office vowed it would ramp up oversight of its cost-estimate process after it underestimated the impact of a Medicare Part D change made by Congress by $4 billion. Source: modernhealthcare.com

www.performrx.com


Patients waiting for shots with new shingles vaccine in short supply July 23, 2018 Local pharmacies are having trouble keeping up with demand for a new Shingles vaccine known as Shingrix, as more patients nationwide seek the vaccination. Shingrix, a two-dose shingles vaccine, is over 90 percent effective at preventing shingles and postherpetic neuralgia (PHN) and remains at 85 percent effectiveness for at least the first four years after vaccination. The Centers for Disease Control and Prevention is recommending the vaccination for people 50 and over, even if they’ve already been vaccinated with the previous shingles vaccination, Zostavax. Source: spokesman.com Trump administration to explore importing prescription drugs July 19, 2018 The Trump administration is exploring ways to safely import certain drugs from foreign countries, part of an effort to lower the price of prescription medicine. The Food and Drug Administration is forming a working group to examine how the U.S. could import pharmaceuticals from abroad “in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities,” the Department of Health and Human Services said in a statement Thursday. Source: thehill.com Proposed US Patient Advocacy Bill Will Toughen Financial Reporting Obligations For Pharma July 19, 2018 In response to concerns that pharmaceutical industry payments could be unduly influencing medical research and practice, US Senator Claire McCaskill of Missouri on June 6 proposed the “Patient Advocacy Transparency Act of 2018”. If adopted, this piece of legislation will require pharmaceutical manufacturers to report payments made to nonprofit organizations and patient advocacy groups, professional societies, clinical trial organizations, and continuing medical education providers. Source: forbes.com Resetting E-Prescriptions for Opioids Helps Curb Use: Study July 18, 2018 Lowering the default number of opioid painkillers in electronic prescription systems reduced overall use of the drugs, a new study finds. In electronic medical-record systems, prescriptions have a default number of pills. It's been suggested that reducing this number may help curb the use of addictive opioids, such as OxyContin. Source: consumer.healthday.com

www.performrx.com


Evidence to support 'breakthrough' drugs often very limited: study July 17, 2018 The 46 medicines given approval through 2017 as part of the U.S. Food and Drug Administration’s Breakthrough Therapy program have often been sent to patients without a large double-blind study, direct measurement of benefit, or comparison with a placebo or existing treatment, according to a new analysis by researchers at Yale University and the Yale School of Medicine. Source: reuters.com Co-Prescription of Opioids and Antidepressants Prevalent in Migraine July 12, 2018 A combination of opioids and selective serotonin reuptake inhibitor (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs) antidepressants was found to be prescribed more frequently than co-prescriptions of opioids plus triptans in patients with a migraine diagnosis, according to a study in Drug, Healthcare and Patient Safety. Source: neurologyadvisor.com Overdoses linked to fentanyl may need multiple doses of antidote naloxone, CDC says July 11, 2018 New and more potent fentanyl may need multiple doses of the overdose antidote naloxone as deaths due to illicit versions of the opioid continue to rise, according to the Centers for Disease Control and Prevention. The agency issued a new public health alert to local health departments and related law enforcement on rising numbers of deaths related to fentanyl and similar products. Source: washingtonexaminer.com FDA wants clearer indications, usage language on product labels July 11, 2018 The FDA has offered more suggestions on product labelling with its latest draft guidance focused on a label's indications and usage section, recommending drug companies make their language as clear as possible to help doctors prescribe the right medicine to patients. Source mmm-online.com

www.performrx.com


RECALLS

Product Type

Product Description

Classification

Code Info Reason for Recall Recalling

Firm

Drugs

Blissful Remedies Red Maeng Da, 100% Mitragyna

Speciosa capsule, 50-count

packaged White Foil Pouche, Dist. by World Organix

LLC, Las Vegas, Nevada UPC#7 22589 32355 3

Class I

Lot Code: 102710. Best by date:

03/2019

Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of

its products due to the potential of high microbial

loads.

World Organix,

LLC

Drugs

Blissful Remedies, 4 Hour Chill, Slow

Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401

88900 3

Class I

Lot Code: 22. Best by

date: 06/2019



loads.

World Organix,

LLC

Drugs

Blissful Remedies Red Maeng Da Liquid Kratom

Mitragyna Speciosa, 12mL

bottle. Distributed by World Organix

LLC Las Vegas Nevada. UPC#7 14983 56525 7

Class I

Lot Code: 2001. Best

by date: 03/2019



loads.

World Organix,

LLC

Drugs

Blissful Remedies Gold Series Ultra

Enhanced Indo, 50 capsule, packaged

in While Foil Pouch, Dist. by World Organix LLC, Las Vegas

Nevada UPC# 6 02401 88900 2

Class I Lot Code:

112710 Exp 03/2019



loads.

World Organix,

LLC

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Blissful Remedies Kratom+CBD CBD

infused Maeng Da, capsules 50-

count packaged in While Foil Pouch.

Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583

27057 4

Class I Lot Code:

112710 Exp 03/2019



loads.

World Organix,

LLC

Drugs

Testosterone Cypionate

Injection, USP, 200 mg/mL, Rx

only, 10 mL vials, Distributed by:

Sun Pharmaceutical Industries, Inc.,

Cranbury, NJ 08512,

Manufactured by: Sun

Pharmaceutical Industries, Ltd.,

Halol-Baroda Highway, Halol-

389 350, Gujarat, India, NDC 62756-

016-40

Class II

Lot #: JKS0280A,

Exp. 06/2019

Presence of Particulate Matter: organic and inorganic

compounds detected in vials of product.

Sun Pharmaceutical

Industries, Inc.

Drugs

Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx

Only, Manufactured by: Zhejiang Huahai Pharmaceutical

Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by:

Solco Healthcare US, LLC Cranbury,

NJ 08512 USA

Class II All lots within expiry

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Prinston Pharmaceutical

Inc.

www.performrx.com


Product Type

Product Description

Classification


Firm

NDC 43547-367-03

Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count

bottle, Rx Only, Manufactured by:

Arrow Pharma (Malta) Ltd. India,

Distributed by: Actavis Pharma,

Inc. Parsippany, NJ 07054, NDC 0591-

2315-19.

Class II

Lot # 1191191M, 1191192M, 1191193M, 1191194M, 1191195M, 1238466M, 1238467M, 1253261M 1256125M, 1277709M


Teva Pharmaceuticals

Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by:



Inc. Parsippany, NJ 07054. NDC 0591-

2316-19

Class II

Lot Numbers:

1191160M, 1191161M, 1191162A, 1219363M, 1219364M, 1219365A, 1225613A, 1233944M, 1233945M, 1253253M, 1253254M



Drugs

Unit Dose Valsartan Tablets,

USP, 80 mg. Rx only, Distributed

by: Major Pharmaceuticals,

Livonia, MI 48152, NDC# 0904-6594-

61.

Class II

Major Label Unit Dose

10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270

(Expiry: 7/18). Lot#


Major Pharmaceuticals

www.performrx.com


Product Type

Product Description

Classification


Firm

T-01466 (Expiry:

7/18). Lot# T-01500

(Expiry:2/19). Lot# T-

01596 (Expiry:

2/19). Lot# T-01625 (Expiry:

2/19). Lot# T-01712 (Expiry:

2/19). Lot# T-01795

(5/19). Lot# T-01807 (Expiry: 5/19)

Drugs

Unit Dose Valsartan Tablets, USP. 160 mg. Rx

only., Distributed by: Major

Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-

6595-61

Class II

Major Label Unit Dose

10 x 10 Cartons 160 mg Item # 302087. Lot# T-01269

(Expiry: 7/18). Lot#

T-01524 (Expiry:

2/19). Lot# T-01646 (Expiry:

5/19). Lot# T-01668 (Expiry:

5/19). Lot# T-01788 (Expiry: 5/19)


Major Pharmaceuticals

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx

Only Manufactured by: Zhejiang Huahai Pharmaceutical



NJ 08512 USA NDC 43547-368-

09




Inc

Drugs

Valsartan, USP, 160 MG Tablets, 90-count bottles,

Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical



NJ 08512 USA NDC 43547-369-

09




Inc

Drugs

Valsartan, USP, 320 MG Tablets, 90-count bottle,

Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical



Class II

All lots within expiry



Inc

www.performrx.com


Product Type

Product Description

Classification


Firm

NJ 08512 USA NDC 43547-370-

09

Drugs

Valsartan and Hydrochlorothiazi

de, USP, 80 MG/12.5 MG

Tablets, 90-count bottles, Rx Only,

Manufactured by: Zhejiang Huahai Pharmaceutical



NJ 08512 USA NDC 43547-311-

09




Inc

Drugs


de, USP, 160 MG/12.5 MG





NJ 08512 USA NDC 43547-312-

09




Inc

Drugs


de, USP, 160 MG/25 MG

Tablets, 90-count bottle, Rx Only,




Inc

www.performrx.com


Product Type

Product Description

Classification


Firm




NJ 08512 USA NDC 43547-313-

09

Drugs


de, USP, 320 MG/12.5 MG

Tablets, 90-count bottle, Rx Only,




NJ 08512 USA NDC 43547-314-

09




Inc

Drugs


de, USP, 320 MG/25 MG





Class II All lots within expiry.



Inc

www.performrx.com


Product Type

Product Description

Classification


Firm

NJ 08512 USA NDC 43547-315-

09

Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets,

USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by:




2317-19.

Class II

Lot Numbers:

1191164M, 1191165M, 1191166M, 1191167A, 1225612M, 1250717M, 1256111M, 1288798M



Drugs

Valsartan and Hydrochlorothi

azide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets,

USP, 90-count bottle, Rx Only,

Rx Only, Manufactured

by: Arrow Pharma (Malta)

Ltd. India, Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054. NDC

0591-2318-19

Class II

Lot Numbers:

1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M



Drugs

Valsartan and Hydrochlorothiazide (HCTZ) Tablets,

USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by:

Class II

Lot Numbers:

1191188M, 1191189M, 1191190M, 1199220M, 1217576M,



www.performrx.com


Product Type

Product Description

Classification


Firm




2318-19.

1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, 1280633M

Drugs

Valsartan Tablets, USP 40 mg, 30-

count bottle (NDC 0591-2167-30), 90-count bottle

(NDC 0591-2167-19), Rx Only, Rx

Only, Manufactured by:



Inc. Parsippany, NJ 07054

Class II

Lot Numbers: NDC 0591-

2167-30 1196936A, 1238463A, 1270617A NDC 0591-

2167-19 1196934M, 1238462M, 1268429A



Drugs


count bottle (NDC 0591-2168-19),

1000-count bottle (NDC 0591-2168-10), Rx Only, Rx





Class II

Lot Numbers: NDC 0591-

2168-19 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, 1250704M NDC 0591-

2168-10 1177114A, 1219360M, 1250706A



www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs








Class II

NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-

2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A



Drugs







Inc. Parsippany, NJ 07054.

Class II

NDC 0591-2170-19 Lot Numbers: 1208002A, 1247282M, 1263944M NDC 0591-

2170-05 Lot Numbers:

1208000M, 1208001M, 1240425A



Drugs

Doxycycline Hyclate Tablets,

USP, 100 mg*. 50-count bottle, Rx

only. Manufactured by:

West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.

Class II

Lot# 71545B,

Expiry date: 01/19

Failed Dissolution Specifications:

West-Ward

Columbus Inc

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Doxycycline Hyclate Tablets, USP, 100 mg*.

500-count bottle, Rx only.

Manufactured by: West-Ward

Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.

Class II

Lot# 71545A,

Expiry date: 07/19

Failed Dissolution Specifications:

West-Ward

Columbus Inc

Drugs

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose

vial per carton, Rx only, Hospira, Inc.,

Lake Forest, IL 60045 USA, NDC

0409-0106-01

Class II

Lot #: 712453A,

Exp 1-Nov-18;

771803A, Exp 1-May-

19; 792103A,

Exp 1-Jul-19; 800903A,

Exp 1-Aug-19;

810853A, Exp 1-Sep-

19; 841703A, 841753A,

Exp 1-Dec-19;

850553A, Exp 1-Jan-20

Microbial Contamination of Sterile Products: Product associated with reports of

adverse events indicative of infusion reactions related to

microbiological contamination.

PFIZER

Drugs

Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only,

Manufactured for: Vensun

Pharmaceuticals, Inc. Yardley, PA

19067, Manufactured by:

Strides Shasun Limited,

Class II

Lot #: 9570024, Exp. Jun-

2019; 9570027, 9570029, Exp. Jul-

2019; 7702088A, 7702089A, Exp. Aug-

2019

Failed Tablet/Capsule Specifications: Tablet breakage

VENSUN PHARMACEUTICAL

S INC

www.performrx.com


Product Type

Product Description

Classification


Firm

Puducherry - 605 014, India, NDC 42543-408-01

Drugs

Indomethacin Capsules, USP, 50

mg, 100-count bottles, Rx only,

Manufactured for: Camber

Pharmaceuticals, Inc., Piscataway,

NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla,

Hyderabad - 500 055, India; NDC 31722-543-01

Class II Lot #:

E180315, Exp 12/19

Failed Tablet/Capsule Specifications: customer complaints of deformed,

clumped, misshaped, melted or stuck together capsules.

Hetero Labs, Ltd.

Drugs

Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only,

Manufactured for: Vensun

Pharmaceuticals, Inc. Yardley, PA

19067, Manufactured by:

Strides Shasun Limited,

Puducherry - 605 014, India, NDC 42543-407-01

Class II

Lot #: 9570012, Exp. June-

2019

Failed Tablet/Capsule Specifications: Tablet breakage

VENSUN PHARMACEUTICAL

S INC

Drugs

Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana,

PA 15701

Class II

Lot # B0318652-

070617; Exp. 07/18


RemedyRepack

Inc.

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana,

PA 15701

Class II

Lot # B0383153-

122917; Exp. 12/18


RemedyRepack

Inc.

Drugs

Doxycycline Hyclate Tablets, USP, 100 mg, Rx

Only, 30 tablets, 3 x 10 unit dose

Cartons, Mfd. by: West-Ward

Pharmaceuticals Corp., Eatontown,

NY 07724; Distributed by:

Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite

233, Livonia, MI 48152 USA. NDC:

0904-0430-04

Class II Lot:

71545AA, exp 7/2019

Failed Dissolution Specifications

MAJOR PHARMACEUTICAL

S

Drugs

Valsartan tablets 160 mg, 90-count

bottle, Rx Only, Repackaged by H.J. Harkins Co,

Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with

343 on one side and HH on the

other side

Class II

Lot # VSA000OV Manufacturer's original

lot # 343B17015,

exp date 02/19 NDC

43547-0369-09

Carcinogen impurity detected in API used to manufacture

drug product.

H J Harkins

Company Inc

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Valsartan 80 mg tablets, 90-count

bottles (NDC 63629-6922-2),

60-count bottles ( 63629-6922-3),

28-count bottles (63629-6922-4),

Rx Only, Packaged by Bryant Ranch,

Burbank, CA 91504

Class II Lot #

111158; Exp. 02/19


Bryant Ranch

Prepack Inc.

Drugs


bottles ( NDC 63629-6905-1),

90-count bottles (NDC 63629-6905-

2), 28-count bottles (NDC

6362-96905-3), Rx Only, Packaged by

Bryant Ranch, Burbank, CA

91504.

Class II

Lot # 114319;

Exp. 10/18 Lot

# 109004;

Exp. 12/18


Bryant Ranch

Prepack Inc.

Drugs


bottles ( NDC 71335-0567-2), Rx Only, Packaged by

Bryant Ranch, Burbank, CA

91504.

Class II

Lot # 120879;

Exp 10/19


Bryant Ranch

Prepack Inc.

Drugs

Dymista (azelastine

hydrochloride and fluticasone

propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx

only, Manufactured by:

Cipla Ltd., Goa,

Class II

Lot #: GA70246, GA70254,

Exp 02/2019

Presence of foreign substance: Potential for glass in the neck

area of the glass bottles.

Mylan Pharmaceuticals

Inc.

www.performrx.com


Product Type

Product Description

Classification


Firm

India, M.L.,, NDC 0037-0245-23

Drugs

Morphine Sulfate 1 mg/mL CADD 25

mL . RX only. Packaged in a CADD 25 ml. Compounded

Guardian Pharmacy

Services, 7920 Elmbrook Dr. Ste.

108C Dallas TX 75247

Class II

Lots: 58440:42 Use By:

05/23/2018; 58624:42 Use By:

06/11/2018; 58962:42 Use By:

07/11/2018

Lack of sterility assurance. Guardian Pharmacy Services

Drugs

Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only.

Packaged in a 100 ml vial.

Compounded Guardian Pharmacy



Class II


05/22/2018; 58703/5873

3 Use By: 06/10/2018;

58852:42 Use By:

06/22/2018; 59006:42 Use By:

07/10/2018

Lack of sterility assurance Guardian Pharmacy Services

Drugs

Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only.

Packaged in 500 ml bag.




Class II

Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42,

Use By: 05/25/2018


www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial.




Class II

Lots: a) 58572:42 Use By:

05/29/2018 b) 58768:42

Use By: 06/20/2018


Drugs

EDTA Disodium 30 mg/mL PF. Rx

Only. Packaged in 1 mL pre filled

syringe. Compounded

Guardian Pharmacy



Class II

Lot: 58897:42 Use By:

07/04/2018


Drugs

Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials.




Class II


05/22/2018; 58653:42 Use By:

06/12/2018; 58773:42, 58766:42,

Use By: 06/21/2018;

58766:42 Use By:

06/20/2018


Drugs

Glycopyrrolate 0.2 mg/mL 2ml. Rx

Only. Packaged in 2 mL syringes. Compounded

Guardian Pharmacy

Services, 7920

Class II

Lot: 58811:93 Use By:

06/18/2018


www.performrx.com


Product Type

Product Description

Classification


Firm

Elmbrook Dr. Ste. 108C Dallas TX

75247

Drugs

Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in

1 mL vials. Compounded

Guardian Pharmacy



Class II

Lot: 58895:42 Use By:

06/27/2018


Drugs

Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in

1 mL syringes. Refridgerate. Compounded

Guardian Pharmacy



Class II


06/27/2018; 58856:42 Use By:

06/21/2018;


Drugs

Magnesium Sulfate 200

mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials.




Class II

Lot: 58212:42 Use By:

06/01/2018


Drugs

Medroxyprogesterone 150 mg/mL

5ml. Rx Only. Packaged in 5 mL

vials. Compounded

Guardian

Class II


06/07/2018; 59099:42 Use By:

07/24/2018;


www.performrx.com


Product Type

Product Description

Classification


Firm

Pharmacy Services, 7920

Elmbrook Dr. Ste. 108C Dallas TX

75247

58786:42 Use By:

06/24/2018

Drugs

Methylene Blue 10 mg/mL 1ml.

Packaged in 1 mL syringes.




Class II


07/30/2018; 58471:42 Use By:

05/27/2018; 58745:42 Use By:

06/10/2018;


Drugs

Fentanyl Citrate 50 mcg/mL 2ml.

Rx Only. Packaged in 2 mL syringes.




Class II


06/28/2018;


Drugs

Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in

a ON-Q Pump. Compounded

Guardian Pharmacy



Class II


05/24/2018; 59159:42 Use By:

05/30/2018


Drugs



Guardian Pharmacy

Class II


05/24/2018; 59163:42 Use By:

05/30/2018


www.performrx.com


Product Type

Product Description

Classification


Firm



Drugs



Guardian Pharmacy



Class II

Lot: 59103:42 Use By:

05/25/2018


Drugs

Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL

syringes. Compounded

Guardian Pharmacy



Class II

Lot: 58758; 58760; 58756,

59095:42, 59093:42; 59091:42


Drugs

Prednisolone Sodium

Phosphate Oral Solution, 15 mg/5

mL, 8 fl oz (237 mL) Bottle, Rx

only, Manufactured By:

Morton Grove Pharmaceuticals,

Inc., Morton Grove, IL 60053, NDC 60432-212-

08.

Class II Lot US1259 Defective Container: Tamper

Evident foil seal not completely intact.

Morton Grove

Pharmaceuticals,

Inc.

Drugs

Kit for the Preparation of

Technetium Tc99m

Medronate, 20mg

Class II Lot 4223

Lack of assurance of sterility: Technetium TC-99M

Medronate Kit has a reported breach of sterility.

Pharmalucence,

Inc.

www.performrx.com


Product Type

Product Description

Classification


Firm

in 10 mL vial, packaged in a) 5-count box (NDC

45567-0040-1), b) 30-count box,

NDC 45567-0040-2 , Rx only,

Manufactured by: Pharmalucence,

Inc., Billerica, MA 01821.

Drugs

Glutathione 200 mg/mL 100

ml. Rx Only. Packaged in 50ml MDV

vials. Compounded

Guardian Pharmacy

Services, 7920 Elmbrook Dr.

Ste. 108C Dallas TX 75247

Class II

Lot: 58653:42 Use By:

06/12/2018; 58773/5876

6 Use By: 06/21/2018;

58766:42 Use By:

06/20/2018


Drugs

Lidocaine 3% 10 ml. Rx Only.

Packaged in 10 mL syringes.




Class II


06/04/2018; 58775:42 Use By:

06/16/2018; 59077:42 Use By:

07/17/2018


Drugs

Glutathione 200 mg/mL 50 ml

MDV. Rx Only. Packaged in 50 mL

vials. Compounded

Guardian Pharmacy


Class II

Lot: 59097:42 Use By:

07/23/2018


www.performrx.com


Product Type

Product Description

Classification


Firm


Drugs

Methylcobalamin 1000 mcg/mL 100

mL. RX Only. Packaged in 100ml

MDV vials. Compounded

Guardian Pharmacy



Class II

Lots: 58409:42,

Use By: 05/21/2018;

58899:42, Use By:

07/04/2018; 59215:42 Use By:

08/01/2018


Drugs

MIC "B" COMBO LIPOTROPIC 50 ml.

Packaged in a 50ml MDV vial. Compounded

Guardian Pharmacy



Class II

Lots: 58618:42

UB, Use By: 06/10/2018


Drugs

Omega-3-Acid Ethyl Esters

Capsules USP, 1 gram* 120-count

bottle Rx Only. Manufactured by:

Banner Pharmacaps, Inc.

High Point, NC 27265.

Manufactured for: Teva

Pharmaceuticals USA Inc. North

Wales, PA 19454 NDC 0093-5401-

89

Class II Lot #

150001420A, EXP 2/2019

API material used in the manufacturing of the product

did not receive regulatory approval prior to release.


www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Lidocaine 2.5% and Prilocaine

Cream, 2.5%. 30g tube, Rx only,

Manufactured by: Hi-Tech Pharmacal

Co., Inc., Amityville, NY 11701, NDC

50383-667-30

Class II Lot #:

356309, Exp. 3/2019

Failed Impurities/Degredation Specifications: Out of

Specification results for an unknown impurity was found during routine stability testing

at 12 months.

Akorn, Inc.

Drugs

10 mcg/mL Fentanyl Citrate

(Preservative Free) in 0.9%

Sodium Chloride 250 mL in 250 mL Intravia Bag and

10 mcg/mL Fentanyl Citrate


Sodium Chloride 100 mL in 150 mL

Intravia Bag, PharMEDium Services, LLC.

Class II

Lot 181760013

D, 181730007

D, Exp 08/09/2018, 09/02/2018

CGMP deviations: Product was released while a hood

certification discrepancy was being investigated.

PharMEDium

Services, LLC

Drugs

5 mg/mL Ephedrine Sulfate


Sodium Chloride 5 mL in 5 mL BD

Syringe Kit Check Tagged,

PharMEDium Services, LLC.

Class II

Lot 181730039

D, Exp 09/20/2018



PharMEDium

Services, LLC

Drugs

10 mg/mL Rocuronium

Bromide (Preservative Free) 5 mL BD

Syringe, PharMEDium Services, LLC.

Class II Lot

181780003D



PharMEDium

Services, LLC

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Valsartan/HCTZ 160/12.5 mg

Tablets, 90-count jar, Rx Only, Packaged by

NuCare Pharmaceuticals, Inc., Orange, CA

92867, NDC 68071-4311-9

Class II

Lot # U01779;

Exp. 04/30/2019


NuCare Pharmaceuticals

Inc

Drugs

Valsartan/HCTZ 160/25mg



92867,

Class II

Lot # T11443;

Exp. 02/28/2019

CGMP Deviations: Carcinogen impurity

detected in API used to manufacture drug product.


Inc

Drugs

Valsartan/HCTZ 320/25mg



92867, NDC 68071-4183-3

Class II

Lot # T11577;

Exp. 06/30/2019



Inc

Drugs

Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml

vials. Compounded

Guardian Pharmacy



Class II


06/05/2018


www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

alba BOTANICA Sensitive Sheer

Shield Sunscreen Fragrance Free spf

50+ , 85 g 3 oz tube.

Manufactured by: The Haine

Celestial Group, Inc. Lake Success, NY, UPC 7 24742

00438 5

Class II Lot code

8041 Microbial Contamination of a

Non-Sterile Product

The Hain Celestial Group,

Inc.

Drugs

Valsartan, 160 mg, 30 tablets per

bottle, Rx Only, Repackaged By:

Northwind Pharmaceuticals, Indianapolis, IN

46256. NDC: 51655-460-52

Class II

Lot: UT4832000

2, exp 07/31/2018;

Lot UT4832000

3, exp 05/31/2019


Northwind

Pharmaceuticals

LLC

Drugs

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx

only, Manufactured for:

Lupin Pharmaceuticals Inc. Baltimore,

Maryland 21202, NDC 68180-980-

03

Class II

Lot #: H800414,

Exp. 12/2019

Presence of Foreign Substance: Product

complaint was received of metal contaminant observed

in one tablet.

Lupin Pharmaceuticals

Inc.

Drugs

Valsartan HCTZ, 160/12.5mg, 30

tablets per bottle, Rx Only,

Repackaged By: Northwind

Pharmaceuticals, Indianapolis, IN

46256. NDC: 51655-950-52

Class II

Lot: UTB237900

03, exp 02/28/2019


Northwind

Pharmaceuticals

LLC

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Atropine 0.01% Opth Solution, 5

mL droptainer, Rx only, Ranier's Rx Laboratory, 1107

Lowry Avenue Suite A, Jeannette,

PA 15644


Lack of Assurance of Sterility: Practices at firm may call into question the

sterility of products intended to be sterile.

Ranier's Compoun

ding Laborator

y

Drugs

DMSO 6.25% Opth Sol, 10 mL

droptainer, Rx only, Ranier's Rx Laboratory, 1107


PA 15644.


Lack of Assurance of Sterility: Practices at firm may call into

question the sterility of products intended to be sterile.

Ranier's Compoun

ding Laborator

y

Drugs

Avastin 1.25 mg/0.05 mL

prefilled syringe, Rx only, Ranier's Rx Laboratory,

1107 Lowry Avenue Suite A, Jeannette, PA

15644.




Ranier's Compoun

ding Laborator

y

Drugs

Triple P (Prostaglandin/Papaverine/Phentola

mine) Injection, 0.008/22.5/0.83

mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx

only, Ranier's Rx Laboratory, 1107


PA 15644.




Ranier's Compoun

ding Laborator

y

Drugs

PR/PA/PH (Prostaglandin/Papaverine/Phentola

mine) Injection, 10mcg/30/1mg/m

L, 10 mL vial, Rx only, Ranier's Rx




Ranier's Compoun

ding Laborator

y

www.performrx.com


Product Type

Product Description

Classification


Firm

Laboratory, 1107 Lowry Avenue

Suite A, Jeannette, PA 15644.

Drugs

Morphine Sulf inhalation,

5mg/3cc, 3cc per vial, Rx only, Ranier's Rx

Laboratory, 1107 Lowry Avenue

Suite A, Jeannette, PA 15644.




Ranier's Compoun

ding Laborator

y

Drugs

Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only,

Ranier's Rx Laboratory, 1107


PA 15644




Ranier's Compoun

ding Laborator

y

Drugs

Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory,


15644.




Ranier's Compoun

ding Laborator

y

Drugs

Medroxyprogesterone 1%

Ophthalmic Solution, 10 mL droptainer, Rx



PA 15644




Ranier's Compoun

ding Laborator

y

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs

Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory,


15644




Ranier's Compoun

ding Laborator

y

Drugs

P/P/P (Prostaglandin/Papaverine/Phentola

mine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only,



PA 15644.




Ranier's Compoun

ding Laborator

y

Drugs

PRASH 12.2mcg/1.22m/1

9.29 (Prostaglandin/Phentolamine/Papav

erine) Injection, 10 mL vial, Rx



PA 15644.




Ranier's Compoun

ding Laborator

y

Drugs

PRO/PA/PH/AT 18mcg/1.8mg/

(Prostaglandin//Papaverine/Phentolamine/Atropine)

Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL,

10 mL vial, Rx only, Ranier's Rx Laboratory, 1107





Ranier's Compoun

ding Laborator

y

www.performrx.com


Product Type

Product Description

Classification


Firm

PA 15644

Drugs

P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentola

mine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only,



PA 15644.




Ranier's Compoun

ding Laborator

y

Drugs

Papav 300/Phent 5mg/10mL

(Papaverine/Phentolamine)

Injection,300 mg/5 mg/10 mL,

10 mL vial, Rx only, Ranier's Rx Laboratory, 1107


PA 15644.




Ranier's Compoun

ding Laborator

y

Drugs

Valsartan, 80mg, 30 tablets per



46256. NDC: 51655-0652-52

Class II

Lot: UT4831000

2, exp 10/31/2018


Northwind

Pharmaceuticals

LLC

Drugs

Valsartan, 320mg, 30 tablets per



46256. NDC: 51655-0654-52

Class II

Lot: UT4810000

1, exp 9/30/2019


Northwind

Pharmaceuticals

LLC

Drugs Valsartan 80 mg Tablets HDPE 90

Class II Lot #

B0335344-CGMP Deviations: Carcinogen impurity detected in API used

RemedyRepack

www.performrx.com


Product Type

Product Description

Classification


Firm

cc bottles in cardboard trays,

Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,

Indiana, PA 15701, NDC 61786-0791-

19

081717, exp. date

08/2018 Lot # B0363364-

110917, exp. date

11/2018 Lot # B0391225-

012218, exp. date

01/2019 Lot # B0408458-

030618, exp. date

03/2019 Lot # B0384871-

010318, exp. date

01/2019 Lot # B0436862-

051518, exp. date 05/2019

to manufacture drug product. Inc.

Drugs

Valsartan 160 mg Tablets, HDPE 90



Indiana, PA 15701, NDC: 61786-0792-

19

Class II

Lot # B0335344-

081717, exp. date

08/2018 Lot # B0363364-

110917, exp. date

11/2018 Lot # B0391225-

012218, exp. date

01/2019 Lot # B0408458-

030618, exp. date

03/2019 Lot # B0384871-

010318, exp. date

01/2019 Lot # B0436862-


RemedyRepack

Inc.

www.performrx.com


Product Type

Product Description

Classification


Firm

051518, exp. date 05/2019

Drugs

Valsartan 320 mg Tablets, HDPE 90



Indiana, PA 15701, NDC 61786-0793-

19

Class II

Lot # B0362988-

110917, exp. date

10/2018 Lot # B0432265-

050318, exp. date

05/2019 Lot # B0450321-

061218, exp. date

06/2019 Lot # B0450322-

061218, exp. date

05/2019 Lot # B0408652-

030718, exp. date 02/2019


RemedyRepack

Inc.

Drugs

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX

only. Packaged By: Aidarex

Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

Class III

Lots: 56698-1, EXP

1/31/2019; 56698-2,

EXP 4/30/2019

Out-of-specification results for the Enalapril Diketopiperazine

degradation product during commercial stability.

Aidarex Pharmaceuticals

LLC

Drugs

Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets

(10 x 10) Unit Dose per carton,

Rx only, Manufactured by:

Wockhardt Limited, H-14/2,

M.I.D.C. Area, Waluj,

Aurangabad,

Class III

Lot #: T-01083, Exp

08/18; DR10447A, Exp 09/18; DS10201A, Exp 07/19; DS10201B, DS10201C, Exp 08/19; DS10319A, Exp 10/19.

Failed Impurities/Degradation Specifications: Sub-recall because this repackaged

product was recalled by the manufacturing firm,

Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine

degradation product.


S

www.performrx.com


Product Type

Product Description

Classification


Firm

Maharashtra, India; Distributed

by: Wockhardt USA LLC., 20

Waterview Blvd., Parsippany, NJ

07054; Distributed by: MAJOR

Pharmaceuticals, 17177 N Laurel

Park Dr., Suite233, Livonia, MI 48152; NDC 0904-5609-

61.

Drugs

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets

(10 x 10) Unit Dose per carton,

Rx only, Manufactured by:

Wockhardt Limited, H-14/2,

M.I.D.C. Area, Waluj,

Aurangabad, Maharashtra,

India; Distributed by: Wockhardt

USA LLC., 20 Waterview Blvd.,

Parsippany, NJ 07054; Distributed

by: MAJOR Pharmaceuticals, 17177 N Laurel

Park Dr., Suite233, Livonia, MI 48152; NDC 0904-5502-

61

Class III

Lot #: T-01082, Exp

08/18; DR10445A, Exp 09/18; DR10443A, Exp 12/18; DR10445B, Exp 03/19; DR10725A, Exp 07/19; DS10024A, DS10040A, Exp 10/19.

Failed Impurities/Degradation Specifications: Sub-recall because this repackaged

product was recalled by the manufacturing firm,

Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine

degradation product.


S

Drugs

Enalapril Maleate, USP 5MG, 90-

count bottle, RX only. Packaged By:

Aidarex

Class III

Lots: 51904-1, EXP:

01/31/2018; 51904-4, 52885-1,




LLC

www.performrx.com


Product Type

Product Description

Classification


Firm

Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

EXP: 03/31/2018;

52885-3, EXP:

04/30/2018; 52885-4,EXP:

05/28/2018; 53840-2,EXP:

5/28/2018; 53840-3,

EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1,

EXP: 01/31/2019;

58596-1, EXP:

05/28/2019.

Drugs

Enalapril Maleate, USP 5MG, 30-

count bottle, RX only. Packaged By:

Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

Class III

Lots: 51904-2, EXP:

01/31/2018; 51904-3,

EXP: 02/28/2018;

51904-5, EXP:

03/31/2018; 52885-2,

EXP: 03/31/2018,

53840-1, EXP:

5/28/2018.




LLC

Drugs

Fluconazole Injection, USP, Iso-

Osmotic Sodium Chloride Diluent, 400 mg in 200 mL

(2 mg/mL), 200 mL Single Dose

Flexible Container bag, Rx only,

Class III Lot #

A061213, Exp 09/18

Superpotent Drug and Failed Stability Specifications: lot out

of specification for elevated sodium chloride and elevated

water vapor.

Renaissance

Lakewood, LLC

www.performrx.com


Product Type

Product Description

Classification


Firm

Manufactured for: Claris Lifesciences

Inc., North Brunswick, NJ

08902; By: Claris Injectables Ltd., Gujarat, India;

NDC 36000-003-06

Drugs

Moxifloxacin Ophthalmic

Solution USP, 0.5%, 5 mL bottle,

Rx only, Manufactured for:

Lupin Pharmaceuticals Inc. Baltimore,

Maryland 21202 United States,

Manufactured by: Lupin Limited

Pithampur (M.P.) 454 775, INDIA, NDC 68180-442-

01

Class III

Lot #: H800393,

Exp. 01/2020

Failed Impurities/Degradation Specifications: An out-of-specification result in the

related substance test during three month long-term stability

study.

Lupin Pharmaceuticals

Inc.

Drugs







08902; By: Claris Injectables Ltd., Gujarat, India,

NDC 36000-002-10

Class III Lot #:

A0A0156, Exp 02/19

Failed Stability Specifications: lot out of specification for

elevated water vapor.

Renaissance

Lakewood, LLC

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs







08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.

Class III

Lot #: a) A060966, A060967, A060965, A061023,

Exp 07/18; b) A060962, Exp 02/19

Superpotent Drug: lots out of specification for elevated

sodium chloride and fluconazole assay.

Renaissance

Lakewood, LLC

Drugs

Testosterone 200 mg Pellet, Rx only,

Carie Boyd's Prescription Shop

122 Grapevine Hwy., Hurst, TX 76054, 800-930-

4361

Class III

Lot #: 061918@08

, Exp.11/28/2

019

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect

expiration date on label

Right Value Drug

Stores, Inc.

Drugs

Levofloxacin Injection in 5%

Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL

Single Use Container bag, Rx

only, Manufactured for: Claris Lifesciences



NDC 36000-046-24.

Class III

Lot #: A061178, A061183, A061236,

Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19

Superpotent Drug: High out of specification results for levofloxacin resulting in

increased concentration of solution.

Baxter Healthcar

e Corporati

on

www.performrx.com


Product Type

Product Description

Classification


Firm

Drugs


Dextrose, 500 mg (5 mg/mL), 500

mg in 100 mL 5% Dextrose, 100 mL





NDC 36000-047-24.

Class III

Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19



Baxter Healthcar

e Corporati

on

Drugs


Dextrose, 750 mg (5 mg/mL), 750

mg in 150 mL 5% Dextrose, 150 mL





NDC 36000-048-24.

Class III

Lot #: A060940, A060948, A060951, A060956, A060958, A060963,

Exp 07/18; A061105, A061110, A061113, A061115, A061119,

Exp 08/18; A061243,

Exp 09/18; A0A0813, Exp 07/19; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp 08/19; A0A0971,



Baxter Healthcar

e Corporati

on

www.performrx.com


Product Type

Product Description

Classification


Firm

A0A0976, Exp 09/19; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, Exp 10/19

Drugs

Diazepam Rectal Gel, 2.5 mg, TWIN

PACK that Contains two pre-filled, unit-dose, rectal delivery systems with

lubricating jelly and instructions

for use per carton, Rx only,

Manufactured for: Oceanside

Pharmaceuticals, a division of

Valeant Pharmaceuticals North America

LLC, Bridgewater, NJ 08807;

Manufactured by: DPT Laboratories, Ltd., San Antonio,

TX 78215; NDC 68682-650-20.

Class III Lot #: NBBN,

Exp 02/22

Labeling: Incorrect or Missing Lot and/or Exp Date: Product

distributed without a lot number or expiration date on

the outer carton.

Valeant Pharmaceuticals North

America LLC

Drugs

Atorvastatin Calcium tablets,

40 mg, 500-count bottle, Rx only,

Mfd By: Dr. Reddy's

Laboratories Limited,

Srikakulam - 532

Class III T60045

Failed Impurities/Degradation Specifications - OOS was

observed for ATV Cyclo FP Impurity and Total Degradation

Impurities tested at the 18 month stability time point in

Atorvastatin Calcium Tablets 40 mg 500 tablets.

Dr. Reddy's

Laboratories, Inc.

www.performrx.com


Product Type

Product Description

Classification


Firm

409 India, NDC 55111-123-05

Drugs

Acne Treatment Pads (2% salicylic acid), packaged in

a 50-count jar, OTC, Distributed by: Greenbrier

International, Inc. 500 Volvo Parkway,

Chesapeake, VA 23320, NDC

71537-001-02

Class III Lot #

2458067, Exp 11/2019

Subpotent drug: The product active ingredient level not matching the exact levels

indicated on the packaging label.

Huijing (Shanghai) Bio-tech Co., Ltd.

Drugs

Contrave (naltrexone HCl and bupropion HCl) Extended-

Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed

by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-

99.

Class III

Lot #: ZCXM, Exp

01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp

09NOV2020; ZCXS,

10NOV2020; ZCXT, Exp

13NOV2020; and ZCXV,

Exp 17NOV2020

Defective Container: Customer complaints of punctures in the

bottle.

Orexigen Therapeutics, Inc.

Biologics

Meningococcal [Groups A, C, Y,

and W 135] Oligosaccharide

Diphtheria CRM197

Conjugate Vaccine

Class III M16095

MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria

CRM(197) Conjugate Vaccine] Solution for intramuscular injection, associated with a

mechanical intervention that is not supported by validation

data, was distributed.

GlaxoSmithKline

Biologicals

*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm

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CURRENT DRUG SHORTAGES

Rocuronium Injection July 25, 2018 Reason for the Shortage

Fresenius Kabi has rocuronium on shortage due to delay of raw materials. Pfizer has rocuronium on shortage due to manufacturing delays. Sagent had rocuronium on shortage due to increased demand. AuroMedics launched rocuronium in mid-2017.

Estimated Resupply Dates

AuroMedics has rocuronium 10 mg/mL 10 mL vials on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290 Mupirocin Calcium 2% Nasal Ointment July 25, 2018 Reason for the Shortage

GlaxoSmithKline states the shortage is due to manufacturing issues. GlaxoSmithKline is looking for an alternative supply source


GlaxoSmithKline has Bactroban Nasal 2% Ointment in 1 gram tubes on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=148 Epinephrine Auto-Injectors July 25, 2018 Reason for the Shortage

Impax was not able to provide a reason for the shortage. Mylan has EpiPen on shortage due to supply constraints.


Impax has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on back order and the company estimates a release date of mid-August 2018 for the 0.15 mg/0.15 mL presentation. The company cannot estimate a release date for the 0.3 mg/0.3 mL presentation.

Mylan has Epipen, EpiPen Jr, and their authorized generic presentations on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420 Spironolactone Tablets July 25, 2018 Reason for the Shortage

Accord, Amneal, Cadista, Mylan, Par, and Sun Pharma did not provide a reason for the shortage.

www.performrx.com


Pfizer states Aldactone is on shortage due to manufacturing delays. Estimated Resupply Dates

Accord has spironolactone 50 mg and 100 mg tablets in 500 count on back order and the company estimates a release date in mid- to late-August 2018. The 25 mg tablets in 100 count and 500 count are on back order and the company estimates a release date in mid-August 2018. The 25 mg 1000 count, 50 mg 100 count, and 100 mg 100 count are on back order and the company estimates a release date of late-July 2018 for the 25 mg 1000 count, early-August 2018 for the 50 mg 100 count, and late-August 2018 for the 100 mg 100 count tablets.

Amneal has all spironolactone presentations on allocation. Jubilant Cadista has spironolactone 25 mg tablets in 500 count and 100 mg tablets in 100 count

on back order and the company estimates a release date in mid-August 2018. The 25 mg and 50 mg tablets in 100 count are on allocation.

Mylan has spironolactone 25 mg, 50 mg, and 100 mg tablets in 100 count unit dose blister packs on back order and the company estimates a release date in early-August 2018 for the 25 mg and 100 mg tablets and the company cannot estimate a release date for the 50 mg tablets. The 25 mg tablets in 100 count and 500 count, 50 mg tablets in 500 count, and 100 mg tablets in 100 count are on intermittent back order and the company is releasing supplies as they become available. The 50 mg tablets in 100 count are on back order and the company estimates a release date in mid-August 2018.

Par has most presentations on back order and the company cannot estimate a release date. Pfizer has Aldactone 100 mg tablets in 100 count on back order and the company estimates a

release date in September 2018. The 25 mg and 50 mg tablets in 100 count are on back order and the company cannot estimate a release date.

Sun Pharma has spironolactone 100 mg tablets in 30 count, 60 count, and 100 count; 25 mg tablets in 500 count and 1000 count; and 50 mg tablets in 100 count on back order and the company estimates a release date in August 2018. The 50 mg tablets in 60 count are on back order and the company cannot estimate a release date. The 100 mg tablets in 500 count are available in limited quantities.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=447 Sodium Acetate Injection July 26, 2018 Reason for the Shortage

American Regent has had sodium acetate on long-term back order for several years. Fresenius Kabi had sodium acetate on shortage due to increased demand. Pfizer had sodium acetate on shortage due to manufacturing delays.


All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=317 Sincalide Injection July 26, 2018 Reason for the Shortage

Bracco Diagnostics has Kinevac injection on shortage due to a supply disruption.

www.performrx.com


There are no approved alternatives to Kinevac for the labeled indications. Estimated Resupply Dates

Bracco has Kinevac on intermittent backorder and on allocation when available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=277 Potassium Chloride Injection July 26, 2018 Reason for the Shortage

Baxter has their highly concentrated potassium chloride in sterile water on shortage because a manufacturing facility has been affected by Hurricane Maria. Baxter has removed these products from distribution and they can be purchased directly if they are in stock. Baxter is also adjusting the allocation of these products. Baxter did not provide a reason for the shortage of their other potassium chloride products.

Fresenius Kabi did not provide a reason for the shortage. Pfizer has potassium chloride injection on shortage due to increase demand. Pfizer

discontinued 2 mEq/mL 250 mL bottles in mid-2018. ICU Medical has potassium chloride injection on shortage due to increased demand. ICU Medical discontinued potassium chloride 10 mEq/500 mL in 5% dextrose and 0.225%

sodium chloride in 2018. Estimated Resupply Dates

Baxter has potassium chloride 20 mEq/1000 mL in lactated ringer's and 5% dextrose on back order and the company cannot estimate a release date.

Baxter has potassium chloride 40 mEq/100 mL and 20 mEq/50 mL in sterile water bags on back order and the company cannot estimate a release date.

Fresenius Kabi has potassium chloride 10 mEq/5 mL, 20 mEq/10 mL, 40 mEq/20 mL, and 60 mEq/30 mL vials on back order and the company estimates a release date of late-July to early-August 2018 for the 5 mL vials and 20 mL vials and the company cannot estimate a release date for the 10 mL and 30 mL vials.

ICU Medical has potassium chloride 20 mEq/1000 mL in 0.9% sodium chloride available in limited supply. Potassium chloride 10 mEq/500 mL in 5% dextrose and 0.45% sodium chloride is on back order and the company estimates a release date of early-September 2018.

Pfizer has potassium chloride 10 mEq/5 mL vials available in limited supply. The 20 mEq/10 mL vials and 40 mEq/20 mL vials are on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=12 Pamidronate Disodium Injection July 26, 2018 Reason for the Shortage

Areva has pamidronate powder for injection available. Mylan Institutional did not provide a reason for the shortage. Pfizer has pamidronate on shortage due to manufacturing delays.

www.performrx.com


Estimated Resupply Dates Mylan Institutional has pamidronate 3 mg/mL and 9 mg/mL 10 mL vials on back order and

the company estimates a release date of late-October to early-November 2018. Pfizer has pamidronate 9 mg/mL 10 mL vials on back order and the company estimates a

release date of August 2018. The 3 mg/mL 10 mL vials are on back order and the company estimates a release date of August 2018. The 6 mg/mL 10 mL vials are on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=402 Nitrofurantoin Oral Suspension July 26, 2018 Reason for the Shortage

Amneal did not provide a reason for the shortage. Casper Pharma and Lupin Pharmaceuticals were not available to provide information. Lupin is no longer manufacturing this product. Nostrum is no longer manufacturing this product. Teva did not provide a reason for the shortage.


Teva has nitrofurantoin oral suspension on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=433 Mannitol Injection July 26, 2018 Reason for the Shortage

American Regent did not provide a reason for the mannitol shortage. Baxter did not provide a reason for the mannitol shortage. Fresenius Kabi had mannitol on shortage due to increased demand. Pfizer has mannitol on shortage due to manufacturing delays.


American Regent has mannitol 250 mg/mL 50 mL vials on back order and the company cannot estimate a release date.

Pfizer has mannitol 250 mg/mL 50 mL vials on back order and the company estimates a release date of October 2018.

BBraun has mannitol 200 mg/mL 250 mL and 500 mL premixed bags on allocation to current customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=341 Hepatitis B Vaccine (Recombinant) July 26, 2018 Reason for the Shortage

Merck has Recombivax HB on shortage due to increase in global demand. GlaxoSmithKline discontinued Engerix B pediatric vials in October 2017.

www.performrx.com



Merck has Recombivax HB adult formulation vials and syringes on back order and the company estimates this will continue through 2018.

Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent vials on back order and the company estimates this will continue through 2018. Merck's limited supply is being allocated to the CDC to ensure use is in accordance with their clinical guidance.

Merck has Recombivax HB dialysis formulation 40 mcg/mL on back order and the company estimates this will continue through 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=320 Fluorescein Sodium Ophthalmic Strips July 26, 2018 Reason for the Shortage

Hub did not provide a reason for the shortage. Akorn did not provide a reason for the shortage.


Akorn has Ful-Glo 0.6 mg and 1 mg strips on allocation. Hub has Bio-Glo 1 mg strips on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=362 Diazepam Injection July 26, 2018 Reason for the Shortage

Pfizer has diazepam on shortage due manufacturing delays. Estimated Resupply Dates

Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=330 Bumetanide Injection July 26, 2018 Reason for the Shortage

Pfizer has bumetanide injection on shortage due to manufacturing delays. Hikma did not provide a reason for the shortage.


Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of 2019.

Hikma has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on a weekly allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307

www.performrx.com


3% and 5% Sodium Chloride Large Volume Injection July 26, 2018 Reason for the Shortage

Baxter has 3% and 5% sodium chloride large volume for injection available. BBraun did not provide a reason for the shortage.


BBraun has 3% sodium chloride 500 mL bags and 5% sodium chloride 500 mL bags on allocation to current customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=415 Vincristine Sulfate Injection July 27, 2018 Reason for the Shortage

Pfizer has vincristine on shortage due to manufacturing delays. Teva has Vincasar available.


Pfizer has vincristine 1 mg/mL 2 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=382 Multiple Vitamins for Infusion July 27, 2018 Reason for the Shortage

Pfizer states the shortage was due to manufacturing delays. Baxter has all presentations fully available at this time.


All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=69 Cefepime Injection July 27, 2018 Reason for the Shortage

Apotex did not provide a reason for the shortage. Baxter had cefepime on shortage due to increased demand. BBraun has cefepime on shortage due to manufacturing delays. Fresenius Kabi had cefepime injection on shortage due to manufacturing delays. Pfizer has Maxipime on shortage due to manufacturing delays. Sagent had cefepime injection on shortage due to manufacturing delays. Sandoz discontinued cefepime injection in early-2016. WG Critical Care had cefepime injection on shortage due to increased demand.

www.performrx.com


Estimated Resupply Dates BBraun has cefepime 1 gram and 2 gram premixed bags on back order and the company

estimates a release date of mid-September 2018. Pfizer has Maxipime 1 gram vials, 2 gram vials, 1 gram ADD-Vantage vials, and 2 gram ADD-

Vantage vials on back order and the company estimates a release date of 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59 Ampicillin Sodium and Sulbactam Sodium Injection July 27, 2018 Reason for the Shortage

Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-Vantage vials. These are on shortage due to manufacturing delays.

Sagent had ampicillin sulbactam vials on back order due to manufacturing delays. Sandoz cannot provide a reason for the shortage. WG Critical Care states the shortage was due to increased demand.


AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Hikma has ampicillin sulbactam 3 gram vials on allocation. The 1.5 gram and 15 gram vials are on back order and the company estimates a release date of August to September 2018.

Mylan Institutional has ampicillin sulbactam 1.5 gram and 15 gram vials on back order and the company estimates a release date of late-August 2018 for the 1.5 gram vials and late-October 2018 for the 15 gram vials.

Pfizer has ampicillin sulbactam 1.5 gram and 3 gram ADD-Vantage vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Methylene Blue July 30, 2018 Reason for the Shortage

Akorn has methylene blue on shortage due to manufacturing delays.[1] American Regent has recently launched an FDA approved presentation, ProvayBlue and

product is available Estimated Resupply Dates

Akorn has methylene blue 10 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=47

www.performrx.com


Indocyanine Green July 30, 2018 Reason for the Shortage

Akorn had IC-Green on shortage due to manufacturing delays. Hub has indocyanine green available.


Akorn has IC-Green 25 mg kits on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=324 Gentamicin Sulfate Ophthalmic Ointment July 30, 2018 Reason for the Shortage

Akorn had Gentak ophthalmic ointment on shortage due to manufacturing delays. Gentamicin ophthalmic solutions are not affected by this shortage.


Akorn has Gentak 3.5 gram tubes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=412 Aminophylline Injection July 30, 2018 Reason for the Shortage

Pfizer has aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has aminophylline 25 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407 Mycophenolate Mofetil Capsules and Tablets July 31, 2018 Reason for the Shortage

Accord did not provide a reason for the shortage. Ascend did not provide a reason for the shortage. Hikma did not provide a reason for the shortage. Mylan did not provide a reason for the shortage. Genentech has Cellcept available. Sandoz did not provide a reason for the shortage.


Accord has limited releases of their mycophenolate presentations.

www.performrx.com


Ascend has all mycophenolate mofetil presentations on intermittent back order and the company is releasing product as it becomes available.

Hikma has all mycophenolate mofetil presentations on allocation. Mylan has mycophenolate mofetil 250 mg capsules in 100 count and 500 count on back

order and the company estimates a release date of late-September 2018 for the 100 count and early-August 2018 for the 500 count. The 500 mg tablets in 100 count and 500 count are on back order and the company estimates a release date of mid-September 2018 for the 100 count and early-August 2018 for the 500 count. The 250 mg and 500 mg capsules in 100 count unit-dose presentations are on back order and the company estimates a release date of late-August 2018 for the 250 mg capsules and early-August 2018 for the 500 mg capsules.

Sandoz has mycophenolate mofetil 250 mg capsules in 500 count on back order and the company estimates a release date of early-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=448 Yellow Fever Vaccine August 1, 2018 Reason for the Shortage

Sanofi Pasteur states the shortage is due to production delays. [1] There are no other suppliers of yellow fever vaccine. Additional information on the yellow fever shortage is available at

http://wwwnc.cdc.gov/travel/news-announcements/yellow-fever-vaccine-shortage-2015. Estimated Resupply Dates

Sanofi Pasteur has YF-Vax multi-dose vials and single dose vials on back order and the company estimates a release date in late-2018.[1]

FDA accepted an investigational new drug application in October 2016. This is for the importation of another yellow fever vaccine from France. The trade name of the imported product is Stamaril. The product information can be found at https://s3.amazonaws.com/filecache.drivetheweb.com/mr5str_sanofipasteur/202281/969800.pdf. The initial rollout began in April 2017. More information can be found at https://www.cdc.gov/mmwr/volumes/66/wr/mm6617e2.htm?s_cid=mm6617e2_w or at https://www.vaccineshoppe.com/index.cfm?fa=anon.content&n=YellowFever&title=

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=197 Metronidazole Hydrochloride Injection August 1, 2018 Reason for the Shortage

Pfizer has metronidazole injection on shortage due to manufacturing delay. BBraun did not provide a reason for the metronidazole injection shortage.


BBraun has metronidazole 100 mL bags on allocation to current customers. Pfizer has metronidazole 100 mL bags in 24 count and 80 count on back order and the

company estimates a release date of August 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316

www.performrx.com


Lorazepam Injection August 1, 2018 Reason for the Shortage

Bedford discontinued lorazepam injection in May, 2011.[1] Hikma has product on shortage due to manufacturing delays.[2] Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017.[3] Akorn has not provided a reason for the shortage.[4] Amphastar has product available.[5]


Hikma has lorazepam 2 mg/mL 10 mL vials on back order and the company estimates a release date of August 2018. The 4 mg/mL 1 mL and 10 mL vials are on back order and the company estimates a release date of August 2018 for the 1 mL vials and September to October 2018 for the 10 mL vials.[2]

Hikma has Ativan 2 mg/mL 1 mL and 10 mL vials on back order and the company estimates a release date of September to October 2018. Ativan 4 mg/mL 1 mL and 10 mL vials are on back order and the company estimates a release date of August 2018.[2]

Pfizer has lorazepam 2 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of July 2018. The 2 mg/mL 10 mL vials are on back order and the company estimates a release date of September 2018. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of July 2018. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 2019.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Ketorolac Injection August 1, 2018 Reason for the Shortage

Alvogen did not provide a reason for the shortage.[1] Amphastar did not provide a reason for the shortage.[2] Athenex did not provide a reason for the shortage.[3] BD RX is now part of Fresenius Kabi.[4] Fresenius Kabi has most ketorolac presentations available.[5] Pfizer has ketorolac injection on back order due to manufacturing delays.[6] Sagent states the reason for the shortage is manufacturing delay.[7] Hikma did not provide a reason for the shortage.[8] Ben Venue closed its plant in Bedford, Ohio in July 2014.[9] Virtus has ketorolac injection available.[10] FDA imposed an import ban in mid-2013 on several Wockhardt products including

ketorolac.[11] Sprix Nasal Spray is not affected by this shortage.[12]


Alvogen has 15 mg/mL 1 mL vials and 30 mg/mL 1 mL vials on back order with unknown release dates.1

www.performrx.com


Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a release date.[2]

Athenex has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of September 2018.[3]

Fresenius Kabi has ketorolac 30 mg/mL 1 mL prefilled syringes available with short expiration dating (< 9 months).[5]

Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes, 30 mg/mL 2 mL Carpuject syringes for intramuscular injection, and 30 mg/mL 1 mL iSecure syringes on back order and the company estimates a release date of 2019. The 15 mg/mL 1 mL vials are available in limited supply.[6]

Sagent has ketorolac 30 mg/mL 1 mL vials and 30 mg/mL 2 mL vials for intramuscular injection on back order and the company cannot estimate a release date.[7]

Hikma has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of August to September 2018.[8]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Diltiazem Hydrochloride Injection August 1, 2018 Reason for the Shortage

Akorn states the reason for the shortage was increased demand due to market conditions. They are not currently producing the 25 mL vials in 10 count.

Pfizer states the reasons for the shortage is manufacturing delays and increases in demand. Hikma has diltiazem injection on shortage due to manufacturing delays caused by increased

demand due to current market conditions. Estimated Resupply Dates

Akorn has diltiazem 5 mg/mL 5 mL and 25 mL vials available in limited supply. The 10 mL vials are on allocation.

Hikma has diltiazem 5 mg/mL 10 mL and 25 mL vials on allocation. The 5 mL vials are on back order and the company estimates a release date of August to September 2018.

Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of August 2018. The 5 mg/mL 5 mL and 10 mL vials are on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Ciprofloxacin Ophthalmic Solution August 1, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage. Novartis has ciprofloxacin ophthalmic solution available. Sandoz has ciprofloxacin ophthalmic solution available.


Akorn has ciprofloxacin ophthalmic solution on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=443

www.performrx.com


Atenolol tablets August 1, 2018 Reason for the Shortage

Almatica Pharma, Mylan, and Sandoz did not provide a reason for the back order. Zydus states increased demand as the reason for the back order. Ranbaxy refuses to provide us with any information regarding drug availability. Major discontinued atenolol 25 mg unit-dose tablets.


Almatica Pharma has Tenormin 25 mg, 50 mg, and 100 mg tablets on intermittent back order and will ship product when available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=334 Atenolol and Chlorthalidone Tablets August 1, 2018 Reason for the Shortage

Almatica Pharma did not provide a reason for the shortage. Mylan has discontinued the production of atenolol/chlorthalidone tablets.


Almatica Pharma has atenolol/chlorthalidone (Tenoretic) 100 mg/25 mg and 50 mg/25 mg tablets on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=449 Fluconazole Injection August 2, 2018 Reason for the Shortage

Baxter, Renaissance Lakewood Pharmaceuticals, and West-Ward did not provide a reason for the fluconazole injection shortage.

Pfizer has fluconazole injection on shortage due to manufacturing delays. Renaissance Lakewood Pharmaceuticals bought fluconazole in sodium chloride premixed

bags from Claris Lifescience. Sagent has new NDC numbers for fluconazole in sodium chloride premixed bags.


Baxter has 200 mg/100 mL and 400 mg/200 mL in 0.9% sodium chloride premixed bags on allocation.

Renaissance Lakewood has fluconazole injection 100 mg/50 mL in 0.9% sodium chloride in 10 count, 200 mg/100 mL in 0.9% sodium chloride in 6 count and 10 count, and 400 mg/200 mL in 0.9% sodium chloride in 6 count and 10 count on back order and the company cannot estimate a release date.

West-Ward has all fluconazole injection presentations on back order. The company cannot estimate a release date for any of the presentations except for the 200 mg/100 mL in 5% dextrose premixed bags, which have an estimated release date of September to October 2018.

www.performrx.com


Sagent has fluconazole injection 200 mg/100 mL in 0.9% sodium chloride on back order and the company has an estimated release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=318 Valsartan and Hydrochlorothiazide Tablets August 6, 2018 Reason for the Shortage

Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Major, Solco, and Teva valsartan tablets are affected by the recall. Alembic, Aurobindo, Cadista, Lupin, Mylan, Macleods, and Novartis are not affected by this

recall. Repackagers may have some presentations affected depending on the source supplier.


Aurobindo has valsartan/hydrochlorothiazide tablets on back order due to the recall and the company cannot estimate a resupply date.

Cadista has valsartan/hydrochlorothiazide tablets on allocation. Major has valsartan/hydrochlorothiazide tablets on back order due to the recall and the

company cannot estimate a resupply date. Mylan has valsartan/hydrochlorothiazide 160 mg/12.5 mg and 160 mg/25 mg tablets on

back order and the company estimates a release date in December 2018. Solco has valsartan/hydrochlorothiazide tablets on back order due to the recall and the

company cannot estimate a resupply date. Teva has valsartan/hydrochlorothiazide tablets on back order due to the recall and the

company cannot estimate a resupply date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=445 Erythromycin Lactobionate Injection August 6, 2018 Reason for the Shortage

Pfizer has Erythrocin on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has Erythrocin 500 mg vials and 500 mg ADD-Vantage vials on back order and the company

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=247 Dipyridamole Injection August 6, 2018 Reason for the Shortage

Hikma did not provide a reason for the shortage.

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Hikma has dipyridamole 5 mg/mL 10 mL vials on a weekly allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=345 Cefuroxime Sodium Injection August 6, 2018 Reason for the Shortage

Sagent has cefuroxime injection on shortage due to manufacturing delays. Teligent discontinued all Zinacef presentations in February 2018. Hikma did not provide a reason for the cefuroxime injection shortage.


Sagent has cefuroxime 750 mg vials on back order and the company cannot estimate a release date.

Hikma has cefuroxime 7.5 gram vials on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13 Atropine Sulfate Injection August 6, 2018 Reason for the Shortage

American Regent had atropine injection on shortage due to market demand. Amphastar has atropine injection available. Pfizer has atropine injection on shortage due to manufacturing delays. Hikma has atropine injection available.


Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes available in limited supply. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates release dates of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 Acetylcysteine Oral and Inhalation Solution August 6, 2018 Reason for the Shortage

American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

Fresenius Kabi has acetylcysteine oral and inhalation solution available. Pfizer had acetylcysteine oral and inhalation solution on shortage due to manufacturing

delays. Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014. Arbor has Cetylev effervescent tablets available. These are for oral use only.


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American Regent has acetylcysteine solution 100 mg/mL 10 mL and 200 mg/mL 10 mL and 30 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has acetylcysteine solution 200 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of late-August 2018. The 100 mg/mL 4 mL and 10 mL vials are on back order and the company estimates a release date of late-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43 5% Dextrose Injection (PVC-free and DEHP-free) August 7, 2018 Reason for the Shortage

ICU Medical states the shortage is due to increased demand and manufacturing delays. ICU Medical discontinued the 500 mL VisIV bags in 2011 due to leaking around the administration and medications ports.

ICU Medical is now the IV fluid business of Pfizer after the acquisition of Hospira. Baxter is not currently marketing 5% dextrose PVC/DEHP-free bags. BBraun has 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on back order due to

manufacturing delays. Estimated Resupply Dates

BBraun has 5% dextrose 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on allocation to current customers.

ICU Medical has 5% dextrose in 100 mL PVC/DEHP-free bags on back order and the company estimates a release date in late-August 2018. The 250 mL PVC/DEHP-free bags are on back order and the company estimates a release date in mid-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=314 5% Dextrose Injection August 7, 2018 Reason for the Shortage

Baxter did not provide a reason for the shortage. ICU Medical states the shortage is due to increased demand. Pfizer states that the shortage is due to increased demand. ICU Medical is now the IV fluid business of Pfizer after the acquisition of Hospira. Pfizer

continues to market the ADD-vantage product. Estimated Resupply Dates

Baxter has 5% dextrose 250 mL, 500 mL, and 1,000 mL bags on allocation. Pfizer has 5% dextrose 250 mL ADD-Vantage bags available in limited supply. ICU Medical has 5% dextrose 250 mL 2 port bags on back order and the company estimates

a release date in late-September 2018. The 500 mL 2 port bags are also on back order and the company estimates a release date in early-September 2018.


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Thiothixene Capsules August 8, 2018 Reason for the Shortage

Mylan did not provide a reason for the shortage. Mylan is the sole supplier of thiothixene.


Mylan has thiothixene 1 mg, 5 mg, and 10 mg capsules in 100 count bottles on back order and the company estimates a release date of 1st quarter 2019.

Mylan Institutional has thiothixene 2 mg and 10 mg capsules in 100 count unit-dose blister packs on back order and the company estimates a release date of late-February 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=418 Theophylline Extended-Release Tablets August 8, 2018 Reason for the Shortage

Major has discontinued theophylline extended-release tablets. Teva cannot provide a reason for the shortage.


Teva has theophylline extended-release tablets temporarily unavailable and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=205 Sterile Talc August 8, 2018 Reason for the Shortage

Lymol has Sclerosol and talc powder on shortage due to manufacturing delays.[1] Novatech SA has Steritalc powder available.[2]


Lymol has Sclerosol and talc powder on long-term back order and the company cannot estimate a release date.[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=260 Reteplase Injection August 8, 2018 Reason for the Shortage

Chiesi USA acquired Cornerstone Therapeutics in March 2014. Cornerstone Therapeutics acquired EKR Therapeutics in June 2012. EKR Therapeutics had

previously purchased Reteplase from PDL BioPharma. Cornerstone Therapeutics was seeking FDA approval of a new supplier of the active

pharmaceutical ingredient for Reteplase: http://crtx.mwnewsroom.com/press-releases/cornerstone-therapeutics-completes-acquisition-of--nasdaq-crtx-0903873.

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Chiesi has Reteplase on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=144 Recombinant Zoster Vaccine (Shingrix) August 8, 2018 Reason for the Shortage

GlaxoSmithKline has Shingrix on shortage due to high demand for the product. Estimated Resupply Dates

GlaxoSmithKline has Shingrix kits in 1 count and 10 count on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=427 Phenytoin Sodium August 8, 2018 Reason for the Shortage

Hikma did not provide a reason for this shortage. X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017.


Hikma has phenytoin sodium 50 mg/mL 2 mL vials and 50 mg/mL 5 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=406 Octreotide Injection August 8, 2018 Reason for the Shortage

Fresenius Kabi has octreotide available. Mylan Institutional has octreotide available. Sagent has octreotide on shortage due to manufacturing delays. Sun Pharma did not provide a reason for the shortage. Teva has octreotide available. Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-

2018. Hikma did not provide a reason for the shortage.


Fresenius Kabi has octreotide 50 mcg/mL 1 mL vials on back order and the company cannot estimate a release date.

Hikma has all presentations available but with short expiration dating. Sagent has 500 mcg/mL 1 mL vials on allocation. Sun Pharma has all octreotide presentations on back order and the company cannot

estimate a release date.

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https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229 Morphine PCA Vials August 8, 2018 Reason for the Shortage

ICU Medical had morphine PCA vials on allocation due to increased demand. [1] Amphastar's morphine PCA vials are not affected by the shortage.[2]


ICU Medical has morphine PCA vials available. [1] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=436 Mineral Oil and Petrolatum Ophthalmic Ointment August 8, 2018 Reason for the Shortage

Allergan states the shortage is due to production delays. Major did not provide a reason for the shortage. Novartis did not provide a reason for the shortage. Rugby did not provide a reason for the shortage. Valeant did not provide a reason for the shortage.

Estimated Resupply Date

Allergan has Refresh PM and Lacri-Lube SOP ointment 3.5 gram tubes on back order and the company cannot estimate a release date. Lacri-Lube SOP 7 gram tubes are also on back order and the company cannot estimate a release date.

Major has Lubrifresh PM ointment 3.5 gram tubes on back order and the company cannot estimate a release date.

Rugby has Artificial Tears 3.5 gram tubes on back order and the company cannot estimate a release date.

Novartis has Genteal PM ointment in 3.5 gram tubes on back order and the company estimates a release date of early-September 2018.

Perrigo has Puralube ointment in 3.5 gram and 1 gram tubes on back order and the company estimates release dates in mid-August 2018.

Bausch Health (previously Valeant) has Soothe Night Time ointment in 3.5 gram tubes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435 Midodrine Tablets August 8, 2018 Reason for the Shortage

Impax discontinued midodrine tablets in July 2018. Mylan did not provide a reason for the shortage. Upsher-Smith did not provide a reason for the shortage.

www.performrx.com


Estimated Resupply Dates Mylan has midodrine 5 mg tablets on back order and the company estimates a release date

in mid-August 2018. Upsher-Smith has midodrine 5 mg and 10 mg tablets in 100-count bottles on intermittent

back order with regular releases. Product is being allocated upon release. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=439 Hydroxocobalamin Injection August 8, 2018 Reason for the Shortage

Meridian Medical Technologies reports that the shortage is due to manufacturing delays and increased demand.


Meridian Medical Technologies has hydroxocobalamin injection 5 gram vials on intermittent back order and the company estimates a release date of September 2018.1

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=446 Eflornithine Hydrochloride Cream August 8, 2018 Reason for the Shortage

Allergan did not provide a reason for the shortage. Estimated Resupply Dates

Allergan has Vaniqa cream on back order and the company estimates a release date in December 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=438 Dexmedetomidine Hydrochloride Injection August 8, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage. Athenex has dexmedetomidine vials available. Fresenius Kabi has dexmedetomidine vials available. Mylan has dexmedetomidine vials available. Par has dexmedetomidine vials available. Pfizer did not provide a reason for the shortage. Sandoz has dexmedetomidine vials available. Teva has dexmedetomidine vials available. Hikma did not provide a reason for the shortage.


Hikma has 100 mcg/mL 2 mL vials on allocation.

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Pfizer has Precedex 4 mcg/mL 50 mL and 100 mL premixed bottles on back order and the company estimates a release date of August 2018. The 4 mcg/mL 20 mL vials are on back order and the company estimates a release date in August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=398 Dexamethasone Sodium Phosphate Injection August 8, 2018 Reason for the Shortage

American Regent has dexamethasone sodium phosphate on shortage due to manufacturing delays.

AuroMedics has dexamethasone sodium phosphate on intermittent back order. Fresenius Kabi has dexamethasone sodium phosphate presentations available. Mylan Institutional has dexamethasone sodium phosphate available. Hikma did not provide a reason for the shortage.


American Regent has dexamethasone sodium phosphate 4 mg/mL products on back order and the company cannot estimate a release date.

AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5mL, and 30 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has dexamethasone sodium phosphate 4 mg/mL 1 mL prefilled syringes on back order and the company estimates a release date of 4th quarter 2018.

Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL and 5 mL vials on back order and the company cannot estimate a release date. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of late-August to early-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Cisplatin Injection August 8, 2018 Reason for the Shortage

Athenex has cisplatin available.[1] Fresenius Kabi has cisplatin available.[2] Mylan Institutional discontinued cisplatin in January 2018.[3] Teva had cisplatin on allocation due to increased demand.[4] WG Critical Care has cisplatin available.[5]


Fresenius Kabi has cisplatin 1 mg/mL 50 mL vials available with short-expiration dating of <9 months.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=96 Ciprofloxacin Oral Suspension August 8, 2018 Reason for the Shortage

Lupin did not provide a reason for the shortage.

www.performrx.com


Bayer has Cipro oral suspension available. Estimated Resupply Dates

Lupin has ciprofloxacin oral suspension on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=255 Chlorothiazide Sodium Injection August 8, 2018 Reason for the Shortage

Akorn had chlorothiazide injection on shortage due to manufacturing delays. Sagent had chlorothiazide injection on shortage due to increased demand. Sun Pharma has chlorothiazide injection available.


American Regent has chlorothiazide 500 mg vials on allocation. Mylan Institutional has chlorothiazide 500 mg vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=365 Belladonna and Opium Suppositories August 8, 2018 Reason for the Shortage

Perrigo has belladonna and opium suppositories on shortage because they are waiting to get more raw ingredient.


Perrigo has belladona and opium 16.3 mg/30 mg and 16.3 mg/60 mg suppositories on back order and the company estimates a release date of 4th quarter 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=425 5% Lidocaine and 7.5% Dextrose Injection August 8, 2018 Reason for the Shortage

Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on shortage due to manufacturing delays.

Pfizer is the sole supplier of this combination. Estimated Resupply Dates

Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on long-term back order and the company estimates a release date of 2019.


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Vancomycin Hydrochloride Injection August 9, 2018 Reason for the Shortage

Alvogen has vancomycin injection available.[1] Athenex has vancomycin injection available.[2] Pfizer has vancomycin vials on back order due to manufacturing delays.[3] Fresenius Kabi has vancomycin injection on shortage due to increased demand.[4] Mylan Institutional has vancomycin injection available.[5] Sagent has vancomycin injection on shortage due to manufacturing delays and increased

demand.[8] Baxter has vancomycin injection available.[6] Samson Medical Technologies has vancomycin injection available.[7]


Fresenius Kabi has vancomycin 5 gram and 10 gram vials on intermittent back order with regular releases.3

Pfizer has vancomycin 500 mg vials, 500 mg ADD-Vantage vials, 750 mg vials, 1 gram vials, and 5 gram vials available in limited supply. The 1 gram ADD-Vantage vials are on back order and the company estimates release dates of August 2018. The 750 mg ADD-Vantage vials are on back order and the company estimates a release date of October 2018. The 10 gram vials are on back order and the company cannot estimate a release date.[3]

Sagent has vancomycin 5 gram and 10 gram vials on back order and the company estimates release dates of August 2018 for the 5 gram vials and October 2018 for the 10 gram vials.[8]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Sodium Polystyrene Sulfonate Oral or Rectal Suspension August 9, 2018 Reason for the Shortage

CMP Pharma did not provide a reason for the shortage. Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene

sulfonate suspension. They cannot estimate when these products will be manufactured again.

Hikma did not provide a reason for the shortage. Estimated Resupply Date

Hikma has sodium polystyrene sulfonate suspension in 60 ml and 120 mL bottles on back order and the company cannot estimate a release date. The 500 mL bottles are on allocation.

CMP Pharma has SPS Suspension on intermittent back order and the company is releasing supplies as they become available.


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Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution August 9, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage. Altaire did not provide a reason for the shortage. Major did not provide a reason for the shortage. Ocusoft did not provide a reason for the shortage. Rugby did not provide a reason for the shortage.


Rugby has Artificial Tears ophthalmic drops on back order and the company cannot estimate a release date.

Major has Liquitears ophthalmic drops on back order and the company cannot estimate a release date.

Akorn has Artificial Tears Solution ophthalmic drops on allocation. Altaire has polyvinyl alcohol ophthalmic drops on back order and the company cannot

estimate a release date. Ocusoft has Tears Again ophthalmic drops in 30 mL bottles available. The 15 mL bottles are

on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=451 Dexpanthenol Injection August 9, 2018 Reason for the Shortage

American Regent has dexpanthenol injection on shortage due to manufacturing delays. There are no other suppliers of dexpanthenol injection.


American Regent has dexpanthenol injection on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=65 50% Dextrose Injection August 9, 2018 Reason for the Shortage

Amphastar has 50% dextrose injection available. Pfizer has 50% dextrose injection on shortage due to manufacturing delays.


Pfizer has 50% dextrose 50 mL LifeShield syringes on back order and the company estimates a release date of August 2018. The 50% dextrose 50 mL Ansyr syringes are available in limited supply.


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Valsartan Tablets August 10, 2018 Reason for the Shortage

Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Camber, Major, Solco, and Teva valsartan tablets are affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Alembic, Aurobindo, Cadista, Lupin, Mylan, Macleods, and Novartis are not affected by this recall.

Repackagers may have some presentations affected depending on the source supplier. Estimated Resupply Dates

Aurobindo has valsartan tablets on intermittent back order and the company is releasing product as it becomes available.

Cadista has valsartan tablets on allocation. Major has valsartan tablets on back order due to the recall and the company cannot

estimate a resupply date. Teva has valsartan tablets on back order due to the recall and the company cannot estimate

a resupply date. Solco has valsartan tablets on back order due to the recall and the company cannot estimate

a resupply date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Metoprolol Injection August 10, 2018 Reason for the Shortage

Alvogen has metoprolol injection available.[1] American Regent has had metoprolol injection on long-term back order for several years.[2] Athenex has metoprolol injection available.[3] Baxter did not provide a reason for the shortage.[4] Fresenius Kabi has metoprolol injection on shortage due to increased demand.[5] Mylan Institutional acquired metoprolol injection from Sagent. They discontinued

metoprolol injection in March 2018.[6] Pfizer has metoprolol injection on shortage due to manufacturing delays.[7] Hikma did not provide a reason for the shortage.[8]


Baxter (formerly Claris) has metoprolol 1 mg/mL 5 mL vials on back order and the company cannot estimate a release date.[4]

Pfizer has metoprolol 1 mg/mL 5 mL ampules and 1 mg/mL 5 mL Carpuject syringes on back order and the company estimates a release date of 2019. The 1 mg/mL 5 mL vials are available in limited supply.[7]

www.performrx.com


Hikma has metoprolol 1 mg/mL 5 mL vials on allocation. The 1 mg/mL 10 mL vials are on back order and the company estimates a release date of late-August to early-September 2018.[8]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=363 Methylphenidate Extended-Release Oral Suspension and Chewable Tablets August 10, 2018 Reason for the Shortage

Pfizer has Quillivant XR on shortage due to manufacturing delays. Pfizer has QuillChew ER chewable tablets available.


Pfizer has Quillivant XR 5 mg/mL extended-release oral suspension in 60 mL bottles and 120 mL bottles on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=373 Labetalol Injection August 10, 2018 Reason for the Shortage

Akorn has labetalol injection available.[1] Alvogen has labetalol injection available.[2] Pfizer has labetalol injection on shortage due to manufacturing delays.[3] Hikma has labetalol injection available.[4]


Hikma has labetalol 5 mg/mL 40 mL vials available with an expiration date of<="" li="" style="box-sizing: border-box;">

Pfizer has labetalol 5 mg/mL 4 mL syringes on back order and the company estimates a release date of August 2018. The 20 mL and 40 mL vials are on back order and the company estimates a release date of November 2018 for the 20 mL vials and August 2018 for the 40 mL vials.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Fluorouracil Injection August 10, 2018 Reason for the Shortage

Accord did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage. Sagent has fluorouracil injection on shortage due to manufacturing delays. Teva has fluorouracil injection on allocation due to increased demand.


Accord has fluorouracil 50 mg/mL 10 mL, 20 mL, 50 mL, and 100 mL vials on intermittent back order and the company is releasing product as it becomes available.

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Fresenius Kabi has fluorouracil 50 mg/mL 50 mL and 100 mL vials on intermittent back order and the company is releasing product as it becomes available.

Sagent has fluorouracil 50 mg/mL 100 mL vials on back order and the company estimates a release date of September 2018.

Teva has Adrucil 50 mg/mL 10 mL, 50 mL, and 100 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=401 Sufentanil Injection August 12, 2018 Reason for the Shortage

Akorn has sufentanil injection on shortage due to increased demand for the product. Hikma did not provide a reason for the shortage. Pfizer has sufentanil injection on shortage due to manufacturing delays.


Akorn has Sufenta 50 mcg/mL 1 mL, 2 mL, and 5 mL ampules on allocation. Hikma has sufentanil 50 mcg/mL 5 mL ampules on back order and the company cannot

estimate a release date. Pfizer has sufentanil 50 mcg/mL 5 mL vials on back order and the company estimates a

release date of December 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=376 Granisetron Hydrochloride Injection August 12, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage. Hikma did not provide a reason for the shortage.


Akorn has granisetron 1 mg/mL 1 mL vials on back order and product will be allocated upon release. The 4 mL vials are on allocation.

Fresenius Kabi has granisetron injection 1 mg/mL 4 mL vials on back order and the company estimates a release date of late-August 2018.

Hikma has granisetron injection 1 mg/mL 1 mL vials on allocation. The 4 mL vials are on back order and the company estimates a release date of August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=428 Epinephrine Injection August 12, 2018 Reason for the Shortage

Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.[1]

Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017.[2]

www.performrx.com


BPI has epinephrine 1 mg/mL 2 mL ampules available.[3] Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.[4]


Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation.[1] Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates

a release date of August 2018.[2] Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an

epinephrine 1 mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Ammonium Molybdate Injection August 12, 2018 Reason for the Shortage

American Regent has ammonium molybdate injection on shortage due to manufacturing delays.

American Regent is the sole supplier to ammonium molybdate injection. Estimated Resupply Dates

American Regent has ammonium molybdate injection on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=11 Aminocaproic Acid Injection August 12, 2018 Reason for the Shortage

Pfizer has aminocaproic acid on shortage due to manufacturing delays. [1] Estimated Resupply Dates

Pfizer has aminocaproic acid 250 mg/mL 20 mL vials available in limited supply.[1] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=346 Meperidine Hydrochloride Injection August 15, 2018 Reason for the Shortage

Pfizer has Demerol injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release date of March 2019. The 25 mg/mL 1 mL Carpuject syringes, 50 mg/mL 1 mL Carpuject syringes, 75 mg/mL 1 mL Carpuject syringes, and 100 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2019. The 50 mg/mL 0.5 mL and 1 mL ampules are on back order and the company estimates a release date of August 2018. The 50 mg/mL 2 mL ampules are on back order and the company estimates a release date of October 2018. The 50 mg/mL 30 mL vials are on back order and

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the company estimates a release date of November 2018. The 50 mg/mL 1.5 mL ampules are available in limited supply.

Hikma has meperidine 100 mg/mL 1 mL vials on back order and the company estimates a release date of late-August to early-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=347 Leucovorin Calcium Injection August 15, 2018 Reason for the Shortage

Fresenius Kabi has leucovorin on shortage due to manufacturing delays and increased demand.

Hikma did not provide a reason for the current shortage. Sagent had leucovorin on shortage due to increased demand. Teva has leucovorin available.


Fresenius Kabi has leucovorin 200 mg vials on back order and the company estimates a release date of late-August 2018.

Hikma has leucovorin 350 mg vials on allocation. The 200 mg vials are on back order and the company estimates a release date of late-August to early-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Alpha-1 Proteinase Inhibitor August 15, 2018 Reason for the Shortage

CSL Behring did not provide a reason for the shortage. The other alpha-1 proteinase inhibitors such as Aralast and Prolastin-C are not affected by

this shortage. Estimated Resupply Dates

CSL Behring has Zemaira 1 mg vials on back order and the company estimates a release of early-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=452 Sodium Bicarbonate Injection August 16, 2018 Reason for the Shortage

Amphastar has sodium bicarbonate injection available.[1] Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays.[2] Fresenius Kabi has reintroduced sodium bicarbonate injection in response to the

shortage.[3] Estimated Resupply Dates

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Pfizer has sodium bicarbonate 4.2% 10 mL LifeShield syringes available in limited supply. The 8.4% 10 mL syringes are on back order and the company estimates a release date of September 2018.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293 Scopolamine Transdermal System August 16, 2018 Reason for the Shortage

Baxter did not provide a reason for the shortage. GlaxoSmithKline has Transderm Scop patches available. Perrigo did not provide a reason for the shortage.


Baxter has Transderm Scop patches on allocation. Perrigo has scopolamine patches on back order and the company cannot estimate a release

date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=442 Remifentanil Injection August 16, 2018 Reason for the Shortage

Mylan Institutional did not provide a reason for the shortage. Fresenius Kabi launched generic remifentanil in January 2018.


Mylan Institutional has Ultiva 1 mg and 5 mg vials on back order and the company estimates a release date of late-August 2018 for the 1 mg vials and mid-November 2018 for the 5 mg vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=371 Progesterone Injection August 16, 2018 Reason for the Shortage

American Regent did not provide a reason for the shortage. Fresenius Kabi has progesterone on shortage due to increased demand and manufacturing

delays. Estimated Resupply Dates

American Regent has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company cannot estimate a release date.

Fresenius Kabi has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company estimates a release date of early-October 2018.


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Moxifloxacin Injection August 16, 2018 Reason for the Shortage

Bayer discontinued Avelox IV in December 2017. Fresenius Kabi had moxifloxacin injection on shortage due to increased demand. Mylan Institutional did not provide a reason for the shortage.


All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=357 Mitoxantrone Hydrochloride Injection August 16, 2018 Reason for the Shortage

Fresenius Kabi has mitoxantrone available.[1] Pfizer has mitoxantrone injection on shortage due to manufacturing delays.[2] Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily

discontinued.[3] Estimated Resupply Dates

Fresenius Kabi has mitoxantrone 2 mg/mL 12.5 mL vials available with an expiration date of <7 months.[1]

Pfizer has mitoxantrone 2 mg/mL 10 mL vials on back order and the company estimates a release date of October 2018.[2]

Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a release date.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=189 Magnesium Sulfate Injection August 16, 2018 Reason for the Shortage

American Regent has had magnesium sulfate unavailable since late 2012. Fresenius Kabi has magnesium sulfate injection on shortage due to increased demand for

the product. Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. X-Gen discontinued magnesium sulfate in April 2018. Exela launched magnesium sulfate vials in May 2018. WG Critical Care has magnesium sulfate injection on shortage due to increased demand for

the product. Estimated Resupply Dates

Fresenius Kabi has magnesium sulfate 500 mg/mL 2 mL, 10 mL, 20 mL and 50 mL vials on back order and the company estimates a release date of late-August 2018 for the 2 mL and 10 mL vials, early- to mid-September 2018 for the 20 mL vials, and late-August 2018 for the 50 mL vials. The 40 mg/mL 50 mL and 100 mL premixed bags are on back order and the

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company estimates a release date of early- to mid-September 2018. The 40 mg/mL 1000 mL premixed bags are on back order and the company estimates a release date of early- to mid-September 2018. The 80 mg/mL 50 mL premixed bags are on back order and the company cannot estimate a release date. The 10 mg/mL 100 mL premixed bags are on back order and the company estimates a release date of early- to mid-September 2018.

Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of November 2018. The magnesium sulfate 10 mg/mL 100 mL bags are on back order and the company estimates a release date of August 2018. The magnesium sulfate 40 mg/mL 50 mL, 100 mL, and 500 mL bags are on back order and the company estimates a release date of August 2018. The 40 mg/mL 1000 mL bags are on back order and the company estimates a release date of September 2018. The 80 mg/mL 50 mL bags are on back order and the company estimates a release date of September 2018.

WG Critical Care has magnesium sulfate 10 mg/mL 100 mL premixed bags on back order and the company estimates a release date of late-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Lactated Ringer's Injection August 16, 2018 Reason for the Shortage

Baxter did not provide a reason for the shortage. BBraun states the reason for the shortage is increased demand. ICU Medical states the reason for the shortage is increased demand.


Baxter has lactated ringer's 250 mL, 500 mL, and 1000 mL bags on allocation. Lactated ringer's with 5% dextrose 500 mL and 1000 mL bags are also on allocation.

BBraun has lactated ringer's injection solution and lactated ringer's with 5% dextrose injection solution products on allocation to current customers.

ICU Medical has lactated ringer's with 5% dextrose 1000 mL bags on back order and the company estimates a release date in late-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=361 Heparin Injection August 16, 2018 Reason for the Shortage

Fresenius Kabi did not provide a reason for the shortage. Pfizer did not provide a reason for the shortage. Sagent had heparin on shortage due to manufacturing delay. Hikma did not provide a reason for the shortage.


Fresenius Kabi has heparin 1,000 unit/mL 10 mL vials and 10,000 unit/mL 0.5 mL preservative free vials on back order and the company estimates a release date in mid-August 2018. The 10,000/mL 4 mL vials are available as short-dated product (<7 months expiration date).

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Hikma has 1,000 unit/mL 30 mL vials and 5,000 unit/mL 10 mL vials on back order and the company cannot estimate a release date. The 5,000 unit/mL 2 mL vials are on back order and the company estimates a release date in late-August to mid-September 2018.

Pfizer has 5,000 unit/mL 1 mL Carpuject syringes on back order and the company estimates a release date of 2019. The 1,000 unit/mL 10 mL and 30 mL vials, 5,000 unit/mL 10 mL vials, and 10,000 unit/mL 1 mL vials are on back order and the company cannot estimate a release date. The 10,000 unit/mL 0.5 mL carpuject syringes, 10,000 unit/mL 1 mL vials, and 5,000 unit/mL 1 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353 Dorzolamide Ophthalmic Solution August 16, 2018 Reason for the Shortage

Akorn has dorzolamide ophthalmic solution on shortage due to manufacturing delays. Merck did not provide a reason for the shortage. Sandoz did not provide a reason for the shortage. Teva discontinued dorzolamide ophthalmic solution in April 2018. Valeant has dorzolamide ophthalmic solution on shortage due to manufacturing delays.


Akorn has dorzolamide 2% ophthalmic solution on allocation. Valeant has dorzolamide 2% ophthalmic solution temporarily unavailable and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=359 Dobutamine Injection August 16, 2018 Reason for the Shortage

Baxter has dobutamine on shortage due to manufacturing delays. Pfizer has dobutamine on shortage due to manufacturing delays.


Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an estimated release date of 2019. The 12.5 mg/mL 20 mL regular vials in 1 count are on back order and the company estimates a release date of October 2018. The 12.5 mg/mL 20 mL regular vials in 10 count are available in limited supply.

Pfizer has dobutamine 1 mg/mL in 250 mL bags on back order and the company estimates a release date of November 2018. The dobutamine 2 mg/mL 250 mL bags are on back order and the company estimates a release date of November 2018. The dobutamine 4 mg/mL 250 mL bags are on back order and the company estimates a release date of November 2018.


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Diclofenac 0.1% Ophthalmic Solution August 16, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage. Rising pharmaceuticals discontinued diclofenac ophthalmic solution. Sandoz did not provide a reason for the shortage.


Akorn has diclofenac 0.1% ophthalmic solution on long-term back order. Sandoz has diclofenac 0.1% ophthalmic solution in 2.5 mL bottles on back order and the

company estimates a release date of late-August 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=395 Deferoxamine Injection August 16, 2018 Reason for the Shortage

Fresenius Kabi has deferoxamine on shortage due to increased demand. Pfizer has deferoxamine on shortage due to manufacturing delays. Novartis has Desferal on shortage due to increased demand. Alvogen launched deferoxamine injection in mid-2018. Apo-Pharma launched deferoxamine injection in mid-2018.


Fresenius Kabi has deferoxamine 500 mg vials on back order and the company estimates a release date of late-August 2018. Check wholesalers for inventory.

Pfizer has deferoxamine 500 mg vials on back order and the company estimates a release date of August 2018.

Novartis has Desferal 500 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393 Clindamycin Phosphate Injection August 16, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage. Alvogen did not provide a reason for the shortage. Baxter has clindamycin injection available. Fresenius Kabi did not provide a reason for the shortage. Pfizer has Cleocin available. Sagent had clindamycin on shortage due to manufacturing delays. Sandoz has clindamycin injection available.


Akorn has clindamycin 900 mg/50 mL in 5% dextrose premixes on back order and the company cannot estimate a release date.

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Alvogen has clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage presentations on back order and the company cannot estimate a release date.

Pfizer has Cleocin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the company estimates a release date of 2019. Cleocin 900 mg/50 mL in 5% dextrose premixed bags, and 600 mg/50 mL in 5% dextrose premixed bags are on back order and the company cannot estimate a release date. The 150 mg/mL 4 mL vials and 300 mg/50 mL in 5% dextrose premixed bags are available in limited supply.

Fresenius Kabi has clindamycin 150 mg/mL 60 mL vials available with an expiration date of <7 months.

Sagent has clindamycin 150 mg/mL 60 mL vials available with an expiration date of March 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=97 Azithromycin Injection August 16, 2018 Reason for the Shortage

AuroMedics did not provide a reason for the shortage. Pfizer has azithromycin injection on shortage due to manufacturing delays. Sun Pharma did not provide a reason for the shortage.


AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing product as it becomes available.

Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380 Ondansetron Hydrochloride Injection August 17, 2018 Reason for the Shortage

Apotex did not provide a reason for the shortage. Athenex has ondansetron injection on shortage due to increased demand. AuroMedics did not provide a reason for the shortage. Fresenius Kabi has ondansetron injection available. Heritage has ondansetron on shortage due to increased demand. Hikma did not provide a reason for the shortage. Mylan Institutional did not provide a reason for the shortage. Pfizer has ondansetron injection on shortage due to manufacturing delays. Sagent has ondansetron injection on shortage due to manufacturing delays. Novartis discontinued Zofran 20 mL vials in May 2018.


Apotex has ondansetron 2 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

Athenex has ondansetron 2 mg/mL 2 mL vials on intermittent back order and the company is releasing product as it becomes available.

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AuroMedics has ondansetron 2 mg/mL 2 mL and 20 mL vials on back order and the company estimates a release date of late-August 2018 for the 2 mL vials and late-September 2018 for the 20 mL vials.

Fresenius Kabi has ondansetron 2 mg/mL 20 mL vials on back order and the company cannot estimate release dates. The 2 mg/mL 2 mL vials and the 2 mg/mL 2 mL prefilled syringes are on back order and the company estimates release dates of mid-September 2018.

Heritage has all ondansetron presentations on allocation. Hikma has ondansetron 2 mg/mL 2 mL and 20 mL vials (NDC 00143-9890-01) vials on allocation.

The 2 mg/mL 20 mL vials (NDC 00641-6079-01) are on back order and the company estimates a release date of September to October 2018.

Mylan Institutional has ondansetron 2 mg/mL 20 mL vials on back order and the company cannot estimate a release date.

Pfizer has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date of August 2018. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of October 2018. The 2 mg/mL 2 mL iSecure syringes are on back order and the company estimates a release date of 2019.

Sagent has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date of August 2018. The 2 mg/mL 20 mL vials are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405 Norepinephrine Bitartrate Injection August 17, 2018 Reason for the Shortage

Baxter did not provide a reason for the shortage. Pfizer has Levophed on shortage due to manufacturing delays. Teva has norepinephrine injection on allocation due to increased demand.


Pfizer has Levophed 1 mg/mL 4 mL ampules on back order and the company estimates a release date of 2020.

Teva has norepinephrine 1 mg/mL 4 mL vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=292 Lidocaine Injection August 17, 2018 Reason for the Shortage

Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the product.

AuroMedics introduced lidocaine injection in February 2014. Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of

raw ingredients. Pfizer has lidocaine presentations on shortage due to manufacturing delays.

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Estimated Resupply Dates AuroMedics has 1% lidocaine 2 mL and 5 mL ampules and 2 mL, 5 mL, and 30 mL vials on

intermittent back order and the company is releasing product as it becomes available. AuroMedics has 2% lidocaine 2 mL ampules and 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has 0.5% Xylocaine 50 mL vials on back order and the company cannot estimate a release date. The 0.5% Xylocaine 50 mL MPF vials are on back order and the company estimates a release date of late-September 2018. The 1% lidocaine 2 mL and 10 mL vials are on back order and the company estimates a release date of early- to mid-September 2018 for the 2 mL vials and late-August 2018 for the 10 mL vials. The 1% Xylocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of late-September 2018 for the 20 mL vials and late-August 2018 for the 50 mL vials. The 1% Xylocaine-MPF 2 mL, 5 mL, and 30 mL vials are on back order and the company estimates a release date of late-August 2018. The 1% Xylocaine-MPF 10 mL vial sterile packs are on back order and the company estimates a release date of mid- to late-August 2018. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine 10 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of late-August 2018 for the 10 mL vials, early-September 2018 for the 20 mL vials, and mid- to late-August 2018 for the 50 mL vials. The 2% Xylocaine-MPF 5 mL vials are on back order and the company estimates a release date of early-September 2018. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of early-September 2018.The 2% lidocaine 5 mL preservative free vials are on back order and the company estimates a release date of mid-to late-August 2018. Check wholesalers for inventory.

Pfizer has 0.5% lidocaine 50 mL tear top vials available in limited supply. The 0.5% lidocaine flip top vials are on back order and the company estimates a release date of October 2018. There is limited short-dated product available. The 1% lidocaine 2 mL preservative-free ampules on back order and the company estimates a release date of August 2018. The 1% lidocaine 5 mL preservative-free ampules are on back order and the company estimates a release date of 2019. The 1% lidocaine 20 mL vials and 30 mL preservative-free vials are on back order and the company estimates a release date of September 2018. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of August 2018. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2018. The 1% lidocaine 5 mL Ansyr syringes are available in limited supply. The 2% lidocaine 2 mL preservative-free ampules are on back order and the company estimates a release date of September 2018. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of 2019. The 2% lidocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of September 2018. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of October 2018. The 2% lidocaine 5 mL Ansyr syringes are available in limited supply. The 4% lidocaine 5 mL ampules are on back order and the company estimates a release date of August 2018.

Hikma has 1% lidocaine 5 mL preservative-free vials on back order and the company estimates a release date of September 2018. The 1% lidocaine 50 mL vials are on allocation. The 2% lidocaine 5 mL preservative-free vials are on allocation. The 2% lidocaine 50 mL vials are on back order and the company estimates a release date of September to October 2018.


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Bupivacaine with Epinephrine Injection August 17, 2018 Reason for the Shortage

Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays.

Estimated Resupply Dates Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the

company estimates a release date of early- to mid-September 2018. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-August 2018. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-August 2018. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of early- to mid-September 2018. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-August 2018. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-August 2018. The 0.75% Sensorcaine with epinephrine 30 mL vials are on back order and the company estimates a release date of early-September 2018.

Pfizer has 0.25% bupivacaine with epinephrine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of October 2018 for the 10 mL vials and August 2018 for the 30 mL vials. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of 2019. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of August 2018. The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019.

Pfizer has 0.25% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019. The 0.5% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of 2019. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Amino Acid Products August 17, 2018 Reason for the Shortage

Baxter has reintroduced amino acids into the distribution channel. Baxter has most amino acid products on allocation due to delays because of Hurricane Maria in

Puerto Rico. BBraun has discontinued FreAmine HBC, Nephramine, and Trophamine 6%.

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ICU Medical has Aminosyn on back order due to an ingredient shortage which has caused a supply disruption.


Baxter has their amino acid products on allocation. ICU Medical has Aminosyn 3.5% 1000 mL bags, Aminosyn 8.5% 500 mL and 500 mL with

electrolytes bags, Aminosyn 10% 500 mL and 1000 mL bags, Aminosyn II 8.5% 500 mL and 500 mL with electrolytes bags, and Aminosyn II 10% 500 mL and 1000 mL bags on back order and the company estimates a release date of 1st quarter 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=297 0.9% Sodium Chloride Small Volume Bags (< 150 mL) August 17, 2018 Reason for the Shortage

Baxter has 0.9% sodium chloride small volume bags on shortage due to manufacturing delays. BBraun has 0.9% sodium chloride small volume bags on shortage due to increased demand. ICU Medical has 0.9% sodium chloride small volume bags on shortage due to increased demand.


Baxter has all 0.9% sodium chloride small volume bags on allocation. BBraun has all 0.9% sodium chloride small volume bags on allocation to current customers only. ICU Medical has all 0.9% sodium chloride small volume bags on back order. The company

estimates release dates in late-August 2018 for the 50 mL VisIV bags, early-September 2018 for the 25 mL and 50 mL bags, mid-September 2018 for the 100 mL bags in 80 count, late-September 2018 for the 50 mL preservative free bags and 100 mL bags in 48 count, and early-October 2018 for the 100 mL VisIV bags.

Pfizer has 0.9% sodium chloride 50 mL Add-Vantage bags and 100 mL Add-Vantage bags available in limited quantities. The 50 mL preservative-free vials are on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352 Vecuronium Bromide Injection August 20, 2018 Reason for the Shortage

Pfizer has vecuronium on shortage due to manufacturing delays. Teva has vecuronium on allocation due to increased demand. Pfizer sold vecuronium injection to Mylan Institutional in December 2013. Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014. Sun Pharma has vecuronium available. Sagent is not marketing vecuronium 10 mg and 20 mg vials. Fresenius Kabi has vecuronium available.


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Mylan Institutional has vecuronium 20 mg vials on back order with an estimated release date of early-January 2019.

Pfizer has vecuronium 10 mg and 20 mg vials on back order and the company estimates a release date of 2019.

Teva has vecuronium 10 mg vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167 Sterile Water for Injection - Large Volume Bags August 20, 2018 Reason for the Shortage

Baxter had sterile water for injection on shortage due to manufacturing delays. BBraun did not provide a reason for the shortage. ICU Medical had sterile water for injection on shortage due to increased demand.


BBraun has sterile water for injection 250 mL and 500 mL bags on allocation to current customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=368 Sterile Water for Injection - Small Volume Vials August 20, 2018 Reason for the Shortage

American Regent has limited availability of sterile water for injection. Fresenius Kabi has sterile water on shortage due to increased demand. Pfizer has sterile water for injection in vials on shortage due to increased demand.


American Regent has sterile water for injection 20 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has sterile water for injection 5 mL, 10 mL, 20 mL, and 50 mL vials on back order and the company estimates a release date of mid-September 2018 for the 5 mL vials, late-August 2018 for the 10 mL vials, early- to mid-October 2018 for the 20 mL vials, and early-October 2018 for the 50 mL vials. The 100 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has sterile water for injection 20 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of September 2018 for the 100 mL vials and August 2018 for the 20 mL and 50 mL vials. The 10 mL vials are available in limited supply.


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Pyridoxine Hydrochloride Injection August 20, 2018 Reason for the Shortage

Fresenius Kabi had pyridoxine on shortage due to manufacturing delays. They are the sole suppliers of pyridoxine injection.


Fresenius Kabi has pyridoxine 100 mg/mL 1 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=450 Prothrombin Complex Concentrate (Kcentra) August 20, 2018 Reason for the Shortage

CSL Behring had short-term delays in product releases.

Estimated Resupply Dates CSL Behring has Kcentra available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=404 Protamine Injection August 20, 2018 Reason for the Shortage

Fresenius Kabi has protamine on a short-term shortage due to increased demand.

Estimated Resupply Dates Fresenius Kabi has protamine 10 mg/mL 5 mL and 25 mL vials on back order and the company

estimates a release date of early-September 2018 for the 5 mL vials and late-August 2018 for the 25 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=453 Nalbuphine Injection August 20, 2018 Reason for the Shortage

Pfizer has nalbuphine or shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has nalbuphine 10 mg/mL 1 mL ampules on back order and the company estimates a

release date of September 2018. The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of October 2018.


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Mupirocin Calcium 2% Cream August 20, 2018 Reason for the Shortage

GlaxoSmithKline is looking for an alternative supply source. Prasco discontinued mupirocin calcium 2% cream in February 2016.


GlaxoSmithKline has Bactroban 2% cream in 15 gram and 30 gram sizes on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=162 Morphine Injection August 20, 2018 Reason for the Shortage

Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.

Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.

Pfizer states the shortage is due to manufacturing delays. Pfizer discontinued morphine ADD-Vantage vials in January 2017.

Pfizer anticipates a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes. Pfizer expects the shortage of prefilled syringe products to recover by late-first quarter 2018.

Hikma did not provide a reason for the shortage. West-Ward is not actively marketing the 15 mg/mL 1 mL vials or the 8 mg/mL 1 mL vials (NDC 00641-6075-25). They are still marketing the 8 mg/mL 1 mL vials with NDC 00641-6126-25.


Fresenius Kabi has morphine 2 mg/mL 1 mL syringes on back order and the company estimates a release date of early-September 2018. The morphine 4 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. The morphine 5 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. The 2 mg/mL 1 mL vials are on back order and the company estimates a release date of late-August 2018. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of late-August to early-September 2018. The 5 mg/mL 1 mL vials and 8 mg/mL 1 mL vials are on back order and the company estimates a release date of late-September 2018. The 10 mg/mL 1 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of August 2018. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company cannot estimate a release date. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL Carpuject syringes, 8 mg/mL 1 mL iSecure syringes, 10 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL Carpuject syringes are on back order and the company

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estimates a release date of June 2019. The 50 mg/mL 20 mL and 50 mL vials are available in limited supply.

Hikma has morphine 10 mg/mL 1 mL vials on allocation. The 4 mg/mL and 8 mg/mL 1 mL vials are on back order and the company estimates a release date of late-August 2018. Infumorph 10 mg/mL 20 mL ampules and 25 mg/mL 20 mL ampules are on back order and the company cannot estimate a release date. Duramorph 1 mg/mL 10 mL ampules are on allocation. Duramorph 0.5 mg/mL 10 mL ampules are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Methotrexate Injection August 20, 2018 Reason for the Shortage

Accord did not provide a reason for the shortage. Fresenius Kabi has methotrexate injection available. Mylan Institutional did not provide a reason for the shortage. Mylan Institutional discontinued

the 40 mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017. Pfizer has methotrexate injection available. Teva had methotrexate injection on shortage due to increased demand. West-Ward has methotrexate injection available.


Pfizer has methotrexate 25 mg/mL 2 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Mepivacaine Injection August 20, 2018 Reason for the Shortage

Fresenius Kabi did not provide a reason for the shortage. Pfizer states the reason for the shortage is manufacturing delays.


Fresenius Kabi has 1% Polocaine-MPF 30 mL vials and 2% Polocaine-MPF 20 mL vials on back order and the company estimates a release date of late-August to early-September 2018. The 1.5% Polocaine-MPF 30 mL vials are on back order and the company estimates a release date of late-August 2018. The 1% Polocaine 50 mL vials are on back order and the company estimates a release date of early-October 2018. The 2% Polocaine 50 mL vials are available with an expiration date of <6 months.

Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose vials, 1% Carbocaine 30 mL preservative-free vials, 1% Carbocaine 50 mL multiple-dose vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of 2019.


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Lorazepam Oral Solution August 20, 2018 Reason for the Shortage

Shortage reasons were not provided.

Estimated Resupply Dates All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=386 Lidocaine with Epinephrine Injection August 20, 2018 Reason for the Shortage

Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays.

Estimated Resupply Dates Fresenius Kabi has 0.5% Xylocaine with epinephrine (1:200,000) 50 mL vials on back order and

the company estimates a release date of early-October 2018. The 1% Xylocaine with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of late-August 2018. The 1% Xylocaine with epinephrine (1:200,000) 20 mL and 50 mL vials are on back order and the company estimates release dates of late-August 2018. The 1% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of late-August to early-September 2018. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 10 mL regular vials and 30 mL vials are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of late-August 2018. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company cannot estimate a release date. The 2% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of early-October 2018. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has 1% lidocaine with epinephrine (1:100,000) 20 mL and 30 mL vials on back order and the company estimates a release date of September 2018. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are available in limited supply. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of October 2018. The 1.5% lidocaine with epinephrine (1:200,000) 5 mL ampules are available in limited supply. The 2% lidocaine with epinephrine (1:100,000) 20 mL and 30 mL vials are available in limited supply. The 2% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of October 2018.

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https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Iron Dextran Injection August 20, 2018 Reason for the Shortage

Allergan had INFeD on shortage due to manufacturing delays. American Regent discontinued Dexferrum injection in 2014.


Allergan has INFeD 50 mg/mL 2 mL vials on back order and the company estimates a release date of early-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=408 Hydroxyethyl Starch in Sodium Chloride Injection August 20, 2018 Reason for the Shortage

BBraun did not provide a reason for the shortage. Pfizer did not provide a reason for the shortage of 6% hetastarch in 0.9% sodium chloride

injection. Pfizer has Voluven available.


BBraun has Hespan 500 mL bags on back order and the company cannot estimate a release date.

Pfizer has 6% hetastarch in 0.9% sodium chloride injection in 500 mL bags on back order and the company estimates a release date in August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=454 Fomepizole Injection August 20, 2018 Reason for the Shortage

Mylan Institutional did not provide a reason for the shortage. X-Gen has discontinued fomepizole.


All marketed presentations are available.


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Doxorubicin Injection August 20, 2018 Reason for the Shortage

Hikma did not provide a reason for the shortage of Adriamycin. Teva has doxorubicin solution for injection on shortage due to increased demand. Fresenius Kabi has doxorubicin solution for injection available. Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials. Pfizer has doxorubicin on shortage due to manufacturing delays. Sagent discontinued doxorubicin solution for injection in late-2017. Mylan Institutional did not provide a reason for the shortage of doxorubicin lyophilized powder

for injection. Athenex has doxorubicin available. FDA was allowing temporary importation of doxorubicin lyophilized powder for injection 50 mg

vials. These vials were manufactured for Hospira UK Limited. The labeling as well as bar coding for the imported product is different from the US version. FDA has the Dear Healthcare Professional Letter linked on their website. The letter includes a link to both the US and United Kingdom package inserts to help explain the differences in labeling and packaging. The link to the letter is http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM507498.pdf. Ordering can be done directly with Hospira Customer Care at 877-946-7747.


Mylan Institutional has doxorubicin lyophilized powder 10 mg vials on back order and the company cannot estimate a release date. The 50 mg vials are on back order and the company estimates a release date of mid-October 2018.

Teva has doxorubicin 2 mg/mL 10 mL vials (NDC 45963-0733-57) on back order and the company will allocate these as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108 Chloroprocaine Hydrochloride Injection August 20, 2018 Reason for the Shortage

Fresenius Kabi did not provide a reason for the shortage. Hikma did not provide a reason for the shortage.


Fresenius Kabi has Nesacaine 20 mg/mL 30 mL vials on back order and the company estimates a release date in late-August 2018. Nesacaine-MPF 30 mg/mL 20 mL vials are on back order and the company estimates a release date in early-September 2018.

Hikma has chloroprocaine hydrochloride injection presentations on allocation.


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Calcium Gluconate Injection August 20, 2018 Reason for the Shortage

American Regent has calcium gluconate on shortage due to manufacturing delays. Fresenius Kabi has calcium gluconate available with alternating short-dating due to

manufacturing process of the vials.

Estimated Resupply Dates American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order and

the company cannot estimate a release date. Fresenius Kabi has calcium gluconate 100 mg/mL 10 mL, 50 mL, and 100 mL vials on back order

and the company estimates a release date of late-August 2018. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=150 Butorphanol Tartrate Injection August 20, 2018 Reason for the Shortage

Pfizer has butorphanol injection on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has butorphanol 2 mg/mL 1 mL and 2 mL vials on back order and the company estimates a

release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=414 Bupivacaine Injection August 20, 2018 Reason for the Shortage

AuroMedics has not provided a reason for the shortage. Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product. Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%

bupivacaine 30 mL glass ampules in December 2017.

Estimated Resupply Dates AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent

back order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has 0.25% Sensorcaine 10 mL preservative-free vials on back order and the company estimates a release date of early-September 2018. The 0.25% 30 mL preservative-free vials are on back order and the company estimates a release date of mid-September 2018. The 0.25% 50 mL vials are on back order and the company estimates a release date of late-August to

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early-September 2018. The 0.5% Sensorcaine 10 mL preservative-free vials are on back order and the company estimates release dates of early-September 2018. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of late-August to early-September 2018. The 0.75% 30 mL preservative-free vials are on back order and the company estimates a release date of late-August to early-September 2018. The 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company cannot estimate release dates.

Pfizer has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of November 2018. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates release dates of August 2018. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of December 2018 for the 10 mL vials and September 2018 for the 30 mL vials. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of October 2018. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of September 2018 for the 10 mL vials and November 2018 for the 30 mL vials. The bupivacaine 0.75% in 8.25% dextrose 2 mL ampules are available in limited supply.

Pfizer has all Marcaine presentations on back order and the company estimates a release date of 2019 except for the Marcaine 0.75% in 8.25% dextrose 2 mL ampules are on back order and the company estimates a release date of September 2018.

Baxter has bupivacaine 0.75% in 8.25% dextrose 2 mL ampules on back order and the company estimates a release date of early-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172 Belatacept Injection August 20, 2018 Reason for the Shortage

Bristol-Myers Squibb has Nulojix in short supply due to manufacturing delays.

Estimated Resupply Dates Bristol-Myers Squibb has limited the distribution of Nulojix. They have product only for existing

patients available through the US Nulojix Distribution Program. They have no estimated recovery date, but do not expect full recovery before the end of 2018. Nulojix is distributed by McKesson Plasma Biologics.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=299 Bacteriostatic 0.9% Sodium Chloride Vials August 20, 2018 Reason for the Shortage

Fresenius Kabi did not provide a reason for the shortage. Pfizer has bacteriostatic sodium chloride vials on shortage due to manufacturing delays.


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Fresenius Kabi has bacteriostatic 0.9% sodium chloride 10 mL and 30 mL vials on back order and the company estimates a release date of mid-September 2018 for the 10 mL vials and late-September 2018 for the 30 mL vials.

Pfizer has bacteriostatic 0.9% sodium chloride 10 mL, 20 mL, and 30 mL vials on back order and the company estimates a release date of December 2018 for the 10 mL vials and September 2018 for the 20 mL and 30 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=441 Abciximab Injection August 20, 2018 Reason for the Shortage

Janssen has Reopro on shortage due to a production interruption at their third party manufacturing site. The contract manufacturer cannot guarantee supply continuity in 2018 and beyond.

There are no other suppliers of abciximab.

Estimated Resupply Dates Janssen has Reopro on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=413 23.4% Sodium Chloride Injection August 20, 2018 Reason for the Shortage

Fresenius Kabi has 23.4% sodium chloride injection on shortage due to increased demand. Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.


Fresenius Kabi has 23.4% sodium chloride 30 mL, 100 mL, and 200 mL vials on back order and the company estimates a release date of early- to mid-September 2018 for the 30 mL and 100 mL vials and late-August 2018 for the 200 mL vials. Check wholesalers for inventory.

Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes August 20, 2018 Reason for the Shortage

Fresenius Kabi did not provide a reason for the shortage. Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing

delays.


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Fresenius Kabi has 0.9% sodium chloride preservative free 10 mL and 20 mL vials on back order and the company estimates a release date of late-August 2018.

Pfizer has 0.9% sodium chloride preservative free 10 mL LifeShield syringes on back order and the company estimates a release date of September 2018. The 10 mL vials are available in limited supply. The 20 mL vials are on back order and the company estimates a release date of October 2018. The 50 mL vials are on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332 Diphenhydramine Injection August 21, 2018 Reason for the Shortage

Pfizer has dipehnhydramine injection on shortage due to manufacturing delays. Hikma did not provide a reason for the shortage. Fresenius Kabi has diphenhydramine injection on shortage due to a short-term manufacturing

delay.

Estimated Resupply Dates Fresenius Kabi has diphenhydramine 50 mg/mL 1 mL vials on back order and the company

estimates a release date of late-August 2018. The 50 mg/mL 1 mL syringes are available with an expiration date of <8 months.

Hikma has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of September 2018.

Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456 Trifluoperazine Tablets August 22, 2018 Reason for the Shortage

Mylan did not provide a reason for the shortage. Upsher-Smith did not provide a reason for the shortage.


Mylan has trifluoperazine 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count bottles on back order and the company estimates a release date of early-December 2018 for the 1 mg tablets and mid-October 2018 for the 2 mg, 5 mg, and 10 mg tablets. The 1 mg, 2 mg, and 10 mg tablets in 100 count unit-dose packs are on back order and the company estimates a release date of early-December 2018 for the 1 mg and 10 mg tablets and mid-October 2018 for the 2 mg tablets.

Upsher-Smith has trifluoperazine 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count bottles on back order and the company estimates a release date of late-fall 2018.


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Indomethacin Capsules August 22, 2018 Reason for the Shortage

Camber did not provide a reason for the shortage. Glenmark has indomethacin on shortage due to manufacturing delays. Heritage discontinued all indomethacin presentations in early-2018. Mylan did not provide a reason for the shortage. Mylan is in the process of discontinuing all

presentations. Sandoz discontinued indomethacin in mid-2016. Teva discontinued all indomethacin presentations in mid-2018.


Camber has indomethacin 25 mg and 50 mg capsules in 100 count on back order and the company estimates a release date of late-August 2018.

Glenmark has indomethacin 50 mg capsules in 100 count and 500 count and 25 mg capsules in 100 count on back order and the company estimates a release date of late-August 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=235 Hydralazine injection August 22, 2018 Reason for the Shortage

Akorn has product on back order due to increased demand. American Regent did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage. X-Gen did not provide a reason for the shortage.


Akorn has hydralazine 20 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

American Regent has hydralazine 20 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release date of late-August 2018.

X-Gen has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release date of late-September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=431 Famotidine Injection August 22, 2018 Reason for the Shortage

Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014. Hikma did not provide a reason for the shortage.

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Pfizer launched famotidine injections in March 2012. Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013. Fresenius Kabi did not provide a reason for the shortage. Baxter has famotidine premixed bags available.


Fresenius Kabi has famotidine 2 mL, 4 mL, and 20 mL vials on back order and the company estimates a release date of late-August 2018. Check wholesalers for inventory.

Mylan Institutional has famotidine 2 mL, 4 mL, and 20 mL vials on back order and the company estimates a release date of late-October 2018 for the 2 mL and 20 mL vials and late-December 2018 for the 4 mL vials.

Hikma has famotidine 4 mL and 20 mL vials on back order and the company estimates a release date of September 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=166 Etomidate Injection August 22, 2018 Reason for the Shortage

American Regent did not provide a reason for the current shortage. AuroMedics has etomidate available. Hikma has etomidate available. Mylan did not provide a reason for the current shortage. Par Sterile Products discontinued etomidate in early 2015. Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate

ampules in October 2016. Sagent is no longer marketing etomidate. Zydus had etomidate on shortage due to an increase in demand.


American Regent has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company cannot estimate a release date.

Mylan Institutional has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of late-October to early-November 2018.

Pfizer has Amidate 2 mg/mL 20 mL LifeShield syringes on back order and the company cannot estimate a release date. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147 Cefoxitin Sodium Injection August 22, 2018 Reason for the Shortage

Apotex did not provide a reason for the shortage. BBraun has cefoxitin on allocation due to increased demand. Fresenius Kabi not provide a reason for the shortage.

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Hikma did not provide a reason for the shortage. Sagent has cefoxitin on shortage due to increased demand. WG Critical Care did not provide a reason for the shortage.


Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company cannot estimate when product will be available again.

BBraun has cefoxitin 1 gram and 2 gram vials on allocation. Hikma has cefoxitin 1 gram, 2 gram, and 10 gram vials on back order and the company estimates

a release date of September 2018 for the 1 gram vials and cannot estimate a release date for the 2 gram and 10 gram vials.

Sagent has cefoxitin 2 gram vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Amiodarone Injection August 22, 2018 Reason for the Shortage

Baxter has Nexterone premixed bags on shortage due to manufacturing delays. Mylan Institutional did not provide a reason for the shortage. Hikma did not provide a reason for the shortage.


Fresenius Kabi has amiodarone 50 mg/mL 3 mL and 9 mL vials available with an expiration date of <8 months for the 3 mL vials and <9 months for the 9 mL vials.

Hikma has amiodarone 50 mg/mL 3 mL in 10 count available with an expiry of December 2018. Mylan Institutional has amiodarone 50 mg/mL 3 mL vials on back order and the company

estimates a release date of late-August 2018. Sagent has 50 mg/mL 3 mL vials available with an expiry of February 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374 Ropivacaine Injection August 23, 2018 Reason for the Shortage

Akorn has ropivacaine on shortage due to increased demand. AuroMedics did not provide a reason for the shortage. Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing

delays. Pfizer has ropivacaine on shortage due to manufacturing delays.


AuroMedics has ropivcaine 10 mg/mL 10 mL vials on intermittent back order and the company is releasing product as it becomes available.

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Pfizer has ropivacaine 2 mg/mL 10 mL vials on back order and the company estimates a release date of October 2018. The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of September 2018.

Fresenius Kabi has Naropin 2 mg/mL 100 mL and 200 mL bottles on back order and the company estimates a release date of late-August 2018 for the 100 mL bottles and early-September 2018 for the 200 mL bottles. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of late-September 2018. The 5 mg/mL 30 mL Steripak ampules are on back order and the company estimates a release date of late-October 2018. The 5 mg/mL 100 mL bottles are on back order and the company estimates a release date of early-October 2018. The 10 mg/mL 20 mL Steripak ampules are on back order and the company estimates a release date of early-September 2018. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Ranitidine Injection August 23, 2018 Reason for the Shortage

Teligent has Zantac IV on shortage due to production delays. Zydus had ranitidine injection on allocation due to increased demand.


Teligent has Zantac 25 mg/mL 2 mL vials on back order and the company estimates a release date of 4th quarter 2018. Zantac 25 mg/mL 40 mL vials (NDC 24987-0364-01) are available but are short-dated.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=426 Nelarabine Injection August 23, 2018 Reason for the Shortage

Novartis did not provide a reason for the shortage. Estimated Resupply Dates

Novartis has Arranon 5 mg/mL 50 mL vials in 1 count and 6 count on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=458 Methadone Injection August 23, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage. Mylan Institutional has methadone injection available.


Akorn has methadone injection on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=358

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Ketamine Injection August 23, 2018 Reason for the Shortage

Hikma did not provide a reason for the shortage. Mylan Institutional did not provide a reason for the shortage. Par has Ketalar on shortage due to increased demand. Pfizer has ketamine on shortage due to manufacturing delays.


Mylan Institutional has ketamine 10 mg/mL 20 mL on back order and the company estimates a release date of early-September 2018. The 50 mg/mL 10 mL vials are on back order and the company estimates a release date of early- to mid-September 2018. The 100 mg/mL 10 mL vials are on back order and the company estimates a release date of late-January 2019.

Pfizer has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on back order and the company estimates a release date of 2019.

Hikma has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on allocation. Par has Ketalar 10 mg/mL 20 mL vials, 50 mg/mL 10 mL vials, and 100 mg/mL 5 mL vials on

back order and the company estimates a release date of mid- to late-September 2018. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Hydromorphone Hydrochloride Injection August 23, 2018 Reason for the Shortage

Akorn has hydromorphone injection on shortage due to increased demand.[1] Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are

focusing their product on the 0.5 mg strength. The launched hydromorphone vials in late-June 2018.[2]

Pfizer did not provide a reason for the shortage.[3] Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[4] Teva did not provide a reason for the shortage.[5] Hikma did not provide a reason for the shortage.[6]


Akorn has hydromorphone 10 mg/mL 1 mL ampules, 5 mL ampules, and 50 mL vials on intermittent back order and the company is allocating product upon release.[1]

Fresenius Kabi has Dilaudid 1 mg/mL 0.5 mL and 1 mg/mL 1 mL syringes on back order and the company estimates a release date of late-August 2018. The 2 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. The hydromorphone 1 mg/mL 1 mL vials and 10 mg/mL 1 mL vials are on back order and the company estimates a release date of early-September 2018. The hydromorphone 2 mg/mL 1 mL vials, 4 mg/mL 1 mL vials, and 10 mg/mL 5 mL, and 50 mL vials are on back order and the company estimates a release date of early- to mid-September 2018[2]

Hikma has hydromorphone 2 mg/mL 20 mL vials on allocation.[6] Pfizer has 2 mg/mL 1 mL vials on back order and the company estimates a release date of

September 2018. The 10 mg/mL 1 mL vials are on back order and the company estimates a

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release date of late-August 2018. The 10 mg/mL 5 mL vials are available in limited supply. The 1 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of early-October 2018. The 2 mg/mL 1 mL Carpuject syringes are available in limited supply. The 10 mg/mL 50 mL vials and 0.5 mg/0.5 mL 0.5 mL iSecure syringes are on back order and the company estimates a release date of March 2019. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL ampules are on back order and the company cannot estimate a release date. The 1 mg/mL 1 mL iSecure syringes, 2 mg/mL 1 mL iSecure syringes, and 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019.[3]

Teva has hydromorphone 10 mg/mL 1 mL, 5 mL, and 50 mL vials on intermittent back order and the company is allocating product upon release.[5]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Haloperidol Tablets August 23, 2018 Reason for the Shortage

Mylan did not provide a reason for the shortage. Estimated Resupply Dates

Mylan has haloperidol 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count unit-dose packs on back order and the company estimates a release date of late-October to early-November 2018. The 0.5 mg tablets in 1000 count bottles are available with an expiration date of May 2019. The 10 mg tablets in 100 count bottles are available with an expiration date of June 2019. The 0.5 mg tablets in 100 count, 1 mg tablets in 100 count and 1000 count, 2 mg tablets in 100 count and 1000 count, 5 mg tablets in 100 count and 1000 count, and 20 mg tablets in 100 count are on back order and the company estimates a release date of late-January 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=459 Furosemide Injection August 23, 2018 Reason for the Shortage

American Regent is not actively marketing furosemide injection. Amneal did not provide a reason for the shortage. Baxter (formerly Claris) did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage. Heritage has furosemide injection available. Pfizer has furosemide injection on shortage due to manufacturing delays and increased

demand. Estimated Resupply Dates

Amneal has furosemide 10 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

Pfizer has furosemide 10 mg/mL 4 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323

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Fentanyl Citrate Injection August 23, 2018 Reason for the Shortage

Akorn has fentanyl injection on shortage due to increased demand. Hikma has fentanyl injection on shortage due to supply and demand issues. Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules

were discontinued in September 2017. Estimated Resupply Dates

Akorn has Sublimaze 50 mcg/mL 2 mL ampules in 10 count and 25 count, and 5 mL ampules in 10 count and 25 count on allocation.

Hikma has fentanyl 50 mcg/mL 2 mL, 20 mL, and 50 mL vials on allocation. The 5 mL vials are on back order and the company estimates a release date of September 2018. The 2 mL, 5 mL, and 20 mL ampules are on back order and the company cannot estimate a release date.

Pfizer has fentanyl 50 mcg/mL 2 mL ampules available in limited supply. The 5 mL ampules are on back order and the company estimates a release date of early-September 2018. The 2 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 2 mL and 20 mL vials are on back order and the company estimates a release date of August 2018 for the 2 mL vials and mid-October 2018 for the 20 mL vials. The 5 mL, 10 mL, and 50 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Etoposide Solution for Injection August 23, 2018 Reason for the Shortage

Accord has etoposide 20 mg/mL 5 mL and 25 mL vials on allocation and 50 mL vials on back order due to increased demand.

Fresenius Kabi has etoposide on back order due to increased demand. Teva has Toposar on allocation due to increased demand. West-Ward did not provide a reason for the shortage. Etoposide phosphate powder for injection (Etopophos) is unaffected by this shortage.


Accord has etoposide 20 mg/mL 5 mL and 25 mL vials on allocation. The 50 mL vials are on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has etoposide 20 mg/mL 5 mL vials on back order and the company estimates a release date of late-August 2018. Check wholesalers for inventory.

Teva has Toposar 20 mg/mL 5 mL, 25 mL, and 50 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=369 Estradiol Valerate Injection August 23, 2018 Reason for the Shortage

Perrigo did not provide a reason for the shortage.

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Estimated Resupply Dates Perrigo has estradiol valerate 20 mg/mL 5 mL vials on back order and the company

estimates a release date of September 2018. The 40 mg/mL 5 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=424 Cefazolin Injection August 23, 2018 Reason for the Shortage

Apotex has discontinued all presentations except cefazolin 10 gram vials. The 10 gram vials are not currently being manufactured.

Baxter did not provide a reason for the shortage. BBraun has cefazolin on shortage due to manufacturing delays. Fresenius Kabi has most cefazolin products available. Pfizer states the reason for the shortage is manufacturing delay. Sagent states the reason for the shortage is manufacturing delays and increased demand. Samson Medical Technologies has cefazolin injection available. Sandoz has cefazolin injection available. Hikma did not provide a reason for the shortage. WG Critical Care did not provide a reason for the shortage.


Baxter has cefazolin 2 gram/100 mL premixed bags on allocation. BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on back order and the company

estimates a release date of mid-September 2018. Fresenius Kabi has cefazolin 500 mg vials on back order and the company estimates a

release date of late-August 2018. The 1 gram vials are on back order and the company estimates a release date of 4th quarter 2018. The 20 gram bulk vials are on back order and the company cannot estimate a release date.

Pfizer has 1 gram vials on back order and the company estimates a release date of 2019. The 10 gram vials are on back order and the company cannot estimate a release date.

Sagent has cefazolin 500 mg, 1 gram, and 10 gram vials on back order and the company estimates a release date of August 2018 for the 500 mg and 10 gram vials and October 2018 for the 10 gram vials.

Sandoz has cefazolin 500 mg and 10 gram vials on back order and the company estimates a release date of early-September 2018 for the 500 mg vials and late-August 2018 for the 10 gram vials.

Hikma has cefazolin 500 mg, 1 gram, and 10 gram vials on allocation. WG Critical Care has cefazolin 1 gram vials on intermittent back order and the company is

releasing product as it becomes available. The 10 gram vials are on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432 *Please refer to ASHP website for more information at: http://www.ashp.org/menu/DrugShortages/CurrentShortages/

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