Topiramate Tablet, Film Coated
FDA Recall NDC 68462-110
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 68462-110). A significant event, classified as Class III, was initiated on Apr 05, 2013 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature."
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 III Terminated
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Apr 05, 2013
May 22, 2013
9624 bottles
Recall Profile & Regulatory Data
Event ID
64995
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Generics Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 09, 2014
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
Batch or Lot Expiration Information
Lot# 02123782, Exp 11/14
Affected Packages Involved in this Recall
68462-108-60Product
68462-108-05Product
68462-108-10Product
68462-153-60Product
68462-153-05Product
68462-153-10Product
68462-109-60Product
68462-109-05Product
68462-109-10Product
68462-110-60Product
68462-110-05Product
68462-110-10Product
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.
