URGENT DRUG RECALL Cetirizine Hydrochloride … · Page 1 of 3 URGENT DRUG RECALL Cetirizine...

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URGENT DRUG RECALL Cetirizine Hydrochloride Chewable Tablets, 5 mg and 10 mg

April 09, 2014

Dear Trading Partner, This notice is to inform you of a drug product recall involving: Drug Product Name: Cetirizine Hydrochloride Chewable Tablets, 5 mg and 10 mg Manufacturer: Sun Pharmaceutical Industries, Ltd NDC Number: For 5 mg: 47335-343-83 (30 CRC)

For 10 mg: 47335-344-83 (30 CRC) and 68016-353-30 (30 CRC). Dosage Form: Chewable Tablet Route of Administration: Oral

Type of Drug Product: Over-The-Counter Intended Use/ Indications: Indicated For the relief of symptoms associated with seasonal allergic rhinitis, perennial allergic rhinitis and also for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria. Package Type and Number of Doses/Sizes: 30 tablets packed in HDPE bottles closed with Child Resistant Caps (CRC). Affected Lot numbers

Product name Pack Size Lot Number Exp. Date

Cetirizine Hydrochloride

Chewable Tablets, 5 mg

30 count CRC pack

JKM2067A 07/2014 JKM2068A 10/2014 JKM2069A 01/2015 JKM6399A 04/2015



30 count CRC pack

JKM2070A 07/2014 JKM2071A 10/2014 JKM2072A 01/2015 JKM2072B 01/2015 JKM6400A 04/2015

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URGENT: DRUG RECALL – RESPONSE FORM Please Complete Form and Fax to: 817-868-5362 Or Email to: [email protected]

We do not have any stock __ _

Or,

Please enter the quantity you shall be returning to Inmar

Product name Lot Number

Batch No. Exp. Date Quantity Being Returned to

Inmar



30 count CRC pack

JKM2067A 07/2014 JKM2068A 10/2014 JKM2069A 01/2015 JKM6399A 04/2015



30 count CRC pack

JKM2070A 07/2014 JKM2071A 10/2014 JKM2072A 01/2015 JKM2072B 01/2015 JKM6400A 04/2015

Name________________________ DEA#________________________

Company__________________________________________________

Address___________________________________________________

City ______________________State _______ Zip Code___________as

Phone Number_____________________ Email___________________

Wholesaler__________________________City/State________________________ For return of affected product, please email [email protected] or call 800-967-5952

Approved As Is Submit New Proof

Signature Date

CSR Jennifer Reese Phone 714-253-0517

Email [email protected]

Fax +1 714-894-6543

Proof Version 5 Job 400302 Proofed On 12/09/2013

Item PJLB1515C (12/2013) (2456204-254) Front of Ply 2

Size & Shape 1.1811 x 4.1339 ROUND CORNER

Description CETIRIZINE HYDROCHLORIDE 5 MG / 30 TABLETS RE-SEAL 3 47335 34383 0

PANTONE 151 PANTONE 136 PANTONE Black

The colors indicated are a representation. Press will match spot colors to the appropriate color guide. Process images will be matched to a color controlled proof.

To avoid delays, please approve this proof by end of day Tuesday December 10, 2013. Return proof to If approving this item by fax, please send this page only


Item PJLB1515C (12/2013) (2456204-254) Back of Ply 2



PANTONE Black


To avoid delays, please approve this proof by end of day Tuesday December 10, 2013.


Item PJLB1515C (12/2013) (2456204-254) Front of Ply 3



PANTONE 151 PANTONE 136 PANTONE Black RELEASE



Approved As Is Submit New Proof

Signature Date


Item PJLB1515C (12/2013) (2456204-257) Panel 1

Size & Shape 2.0625 x 5.0

Description ONSERT CETIRIZINE HYDRCHL 3 UP 5 MG / 30 TABLETS

AQUEOUSCOATING

PANTONEProces Black

PANTONEProces Black




Item PJLB1515C (12/2013) (2456204-257) Panel 2






Item PJLB1515C (12/2013) (2456204-257) Panel 3






Item PJLB1515C (12/2013) (2456204-257) Panel 4






Item PJLB1515C (12/2013) (2456204-257) Panel 5






Item PJLB1515C (12/2013) (2456204-257) Panel 6






Item PJLB1515C (12/2013) (2456204-257) Panel 7






Item PJLB1515C (12/2013) (2456204-257) Panel 8





Labeling Format Information:Fonts: Helvetica narrow, bold, oblique, bold obliqueDrug Facts:Header:Body Text:Subheader:Drug Facts (continued):

Horizontal Scale: 85-100% Average Kerning: 0

Leading:Bullets:Barlines:Hairlines:

6.5pt6pt1pt.5pt

TAM-ART, INC. SBGG#: 302769-4 Part No. & Iss.: PJLB1402A Iss. 10-2011 Description: Cetirizine OTC Final Size: 4.5 x 1.625mg Size: 10 / Tablet Count: 30Colors: (3) Black, 2573, 151UnVarnish Area: 0.7736" x 0.3" PDF Proof - Round 3 11/28/11 11:30 am

This proof is for color break only.Please refer to The Pantone® Matching System swatches for accuratecolor. This color WILL NOT MATCH your final printed labels.

Pantone 144

Pantone 2573

BlackP

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PJL

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PJL

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PJLB1402A PJLB1402A ISS. 10/2011

GUJ/DRUGS/25/789

Batch No.:

Exp.:

Open for Full LabelingNDC 47335-344-83

10 mg

Children’s

Original Prescription Strength

Distributed by:Caraco Pharmaceutical Laboratories, Ltd.1150 Elijah McCoy Drive, Detroit, MI 48202

24 Hour Relief of:

• Runny Nose

Cetirizine HydrochlorideChewable Tablets

ALLERGY AntihistamineTutti-frutti FlavorIndoor & Outdoor Allergies

30 CHEWABLE TABLETS6 yrs. & older

pjlb1402a_chtab10

DO NOT USE IF INNER SAFETY SEALIMPRINTED WITH “SEALED forYOUR PROTECTION” IS TORN ORMISSING

Manufactured by:Sun Pharmaceutical Ind. Ltd.Halol-Baroda Highway,Halol-389 350, Gujarat, India.

• sto

re b

etwe

en 2

0° to

25°

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if inn

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seal

is op

en o

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n• s

ee to

p lay

er fo

r lot

num

ber a

nd e

xpira

tion

date

• Sneezing • Itchy, Watery Eyes• Itchy Throat or Nose

9pt8pt6pt6pt8pt

DieCut [does not print]

Pattern Varnish Area

Pantone 144 @ 30%

URGENT DRUG RECALL Cetirizine Hydrochloride … · Page 1 of 3 URGENT DRUG RECALL Cetirizine...

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