Recalls / Class III
Class IIID-0255-2022
Product
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.
- Brand name
- Topiramate
- Generic name
- Topiramate
- Active ingredient
- Topiramate
- Route
- Oral
- NDCs
- 29300-115, 29300-116, 29300-117, 29300-118
- FDA application
- ANDA090162
- Affected lot / code info
- Lot #: ZTPM20044, Exp. Date 09/30/2022
Why it was recalled
Discoloration
Recalling firm
- Firm
- UNICHEM PHARMACEUTICALS USA INC
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 2200, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 1284 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-10-25
- FDA classified
- 2021-11-19
- Posted by FDA
- 2021-12-01
- Terminated
- 2022-10-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0255-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.