Drug product
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
D-0001-2025
Product summary
- Event
- Event 95418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2328 bottles
- Official record key
drug-enforcement:D-0001-2025
Official wording
Reason: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Code information: Lot #: U24T0408A, Exp: 03/31/2026
Distribution pattern: Nationwide within the U.S
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets