Drug 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.
D-0255-2022
Product summary
- Event
- Event 88891
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1284 bottles
- Official record key
drug-enforcement:D-0255-2022
Official wording
Reason: Discoloration
Code information: Lot #: ZTPM20044, Exp. Date 09/30/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Discoloration