FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Zydus Pharmaceuticals TOPIRAMATE Tablets 200 mg Recall

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only

Zydus Pharmaceuticals USA Inc · Pennington, NJ

Risk level
Class II
Reported by FDA
Oct 22, 2014
Recall ID
D-0015-2015
Check your lot numberHow we source this data

Summary

Zydus Pharmaceuticals recalled TOPIRAMATE Tablets 200 mg starting Sep 15, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0015-2015 on Oct 22, 2014. Reason: Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Product description

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.

Lot numbers, UPCs & expiration codes

Lot #: MN9828, Expiry: Oct 2015.

Where it was sold

U.S. 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-0015-2015
Classification
Class II
Status
Terminated
Recall initiated
Sep 15, 2014
FDA report date
Oct 22, 2014
Quantity
14,568 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Zydus Pharmaceuticals USA Inc

Original FDA data

Every field from FDA enforcement report D-0015-2015, exactly as published.

Show all FDA fields
City
Pennington
State
NJ
Status
Terminated
Country
United States
Event ID
69387
Address
73 Route 31 N
Code information
Lot #: MN9828, Expiry: Oct 2015.
Postal code
08534-3601
Report date
Oct 22, 2014
Product type
Drugs
Recall number
D-0015-2015
Classification
Class II
Recalling firm
Zydus Pharmaceuticals USA Inc
Product quantity
14,568 Bottles
Termination date
Sep 20, 2017
Reason for recall
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Voluntary / mandated
Voluntary: Firm initiated
Product description
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Distribution pattern
U.S. Nationwide
Recall initiation date
Sep 15, 2014
Initial firm notification
Letter
Center classification date
Oct 10, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0015-2015, published Oct 22, 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls