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Class III: unlikely to cause harmTerminated

Caraco Pharmaceutical Laboratories Cetirizine Hydrochloride Chewable Tablets Recall

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by S…

Caraco Pharmaceutical Laboratories, Ltd. · Detroit, MI

Risk level
Class III
Reported by FDA
May 7, 2014
Recall ID
D-1296-2014
Check your lot numberHow we source this data

Summary

Caraco Pharmaceutical Laboratories recalled Cetirizine Hydrochloride Chewable Tablets starting Apr 9, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1296-2014 on May 7, 2014. Reason: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Product description

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

Lot numbers, UPCs & expiration codes

JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1296-2014
Classification
Class III
Status
Terminated
Recall initiated
Apr 9, 2014
FDA report date
May 7, 2014
Quantity
128,363 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Caraco Pharmaceutical Laboratories, Ltd.

Original FDA data

Every field from FDA enforcement report D-1296-2014, exactly as published.

Show all FDA fields
City
Detroit
State
MI
Status
Terminated
Country
United States
Event ID
67971
Address
1150 Elijah McCoy Dr
Code information
JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
Postal code
48202-3344
Report date
May 7, 2014
Product type
Drugs
Recall number
D-1296-2014
Classification
Class III
Recalling firm
Caraco Pharmaceutical Laboratories, Ltd.
Product quantity
128,363 bottles
Termination date
Oct 7, 2014
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Voluntary / mandated
Voluntary: Firm initiated
Product description
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Distribution pattern
Nationwide
Recall initiation date
Apr 9, 2014
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 1, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1296-2014, published May 7, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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