Topiramate Tablet, Film Coated
FDA Recall NDC 29300-116
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 29300-116). A significant event, classified as Class III, was initiated on Oct 25, 2021 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Discoloration"
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
Discoloration
Oct 25, 2021
Dec 01, 2021
1284 bottles
Recall Profile & Regulatory Data
Event ID
88891
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
UNICHEM PHARMACEUTICALS USA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 12, 2022
Product Description
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.
Batch or Lot Expiration Information
Lot# : ZTPM20044, Exp. Date 09/30/2022
Affected Packages Involved in this Recall
29300-115-16Product
29300-115-01Product
29300-115-05Product
29300-115-10Product
29300-116-16Product
29300-116-01Product
29300-116-05Product
29300-116-10Product
29300-117-16Product
29300-117-01Product
29300-117-05Product
29300-117-10Product
29300-118-16Product
29300-118-01Product
29300-118-05Product
29300-118-10Product
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.
