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Class II: temporary or reversible health riskTerminated

Caraco Pharmaceutical Laboratories Metformin HCl Extended-Release Tablets Recall

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manuf…

Caraco Pharmaceutical Laboratories, Ltd. · Detroit, MI

Risk level
Class II
Reported by FDA
Mar 5, 2014
Recall ID
D-1089-2014
Check your lot numberHow we source this data

Summary

Caraco Pharmaceutical Laboratories recalled Metformin HCl Extended-Release Tablets starting Jan 28, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1089-2014 on Mar 5, 2014. Reason: Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER. Status: Terminated.

Why it was recalled

Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Product description

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02

Lot numbers, UPCs & expiration codes

Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016

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-1089-2014
Classification
Class II
Status
Terminated
Recall initiated
Jan 28, 2014
FDA report date
Mar 5, 2014
Quantity
2528 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Caraco Pharmaceutical Laboratories, Ltd.

Original FDA data

Every field from FDA enforcement report D-1089-2014, exactly as published.

Show all FDA fields
City
Detroit
State
MI
Status
Terminated
Country
United States
Event ID
67433
Address
1150 Elijah McCoy Dr
Code information
Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016
Postal code
48202-3344
Report date
Mar 5, 2014
Product type
Drugs
Recall number
D-1089-2014
Classification
Class II
Recalling firm
Caraco Pharmaceutical Laboratories, Ltd.
Product quantity
2528 bottles
Termination date
Sep 29, 2014
Reason for recall
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Voluntary / mandated
Voluntary: Firm initiated
Product description
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02
Distribution pattern
Nationwide
Recall initiation date
Jan 28, 2014
Initial firm notification
E-Mail
Center classification date
Feb 26, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1089-2014, published Mar 5, 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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