Topiramate Tablet, Film Coated
FDA Recall NDC 68382-138
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Topiramate (NDC 68382-138). A significant event, classified as Class II, was initiated on Sep 15, 2014 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Sep 15, 2014
Oct 22, 2014
14,568 Bottles
Recall Profile & Regulatory Data
Event ID
69387
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Sep 20, 2017
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.
Batch or Lot Expiration Information
Lot# : MN9828, Expiry: Oct 2015.
Affected Packages Involved in this Recall
68382-138-14Product
68382-138-16Product
68382-138-01Product
68382-138-05Product
68382-139-14Product
68382-139-16Product
68382-139-01Product
68382-139-05Product
68382-140-14Product
68382-140-16Product
68382-140-01Product
68382-140-05Product
68382-141-14Product
68382-141-16Product
68382-141-01Product
68382-141-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
