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Class III: unlikely to cause harmTerminated

Glenmark Topiramate Tablets Recall

Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Man…

Glenmark Generics Inc., USA · Mahwah, NJ

Risk level
Class III
Reported by FDA
May 22, 2013
Recall ID
D-331-2013
Check your lot numberHow we source this data

Summary

Glenmark Generics recalled Glenmark Topiramate Tablets starting Apr 5, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-331-2013 on May 22, 2013. Reason: Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature. Status: Terminated.

Why it was recalled

Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.

Product description

Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430

Lot numbers, UPCs & expiration codes

Lot# 02123782, Exp 11/14

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-331-2013
Classification
Class III
Status
Terminated
Recall initiated
Apr 5, 2013
FDA report date
May 22, 2013
Quantity
9624 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Glenmark Generics Inc., USA

Original FDA data

Every field from FDA enforcement report D-331-2013, exactly as published.

Show all FDA fields
City
Mahwah
State
NJ
Status
Terminated
Country
United States
Event ID
64995
Address
750 Corporate Dr
Code information
Lot# 02123782, Exp 11/14
Postal code
07430-2009
Report date
May 22, 2013
Product type
Drugs
Recall number
D-331-2013
Classification
Class III
Recalling firm
Glenmark Generics Inc., USA
Product quantity
9624 bottles
Termination date
Oct 9, 2014
Reason for recall
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
Distribution pattern
Nationwide
Recall initiation date
Apr 5, 2013
Initial firm notification
Letter
Center classification date
May 16, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-331-2013, published May 22, 2013. 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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