D-0001-2025 Class II Terminated
FDA drug recall D-0001-2025 was initiated by Nivagen Pharmaceuticals Inc on September 24, 2024 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated July 1, 2026). Affected quantity: 2328 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 9, 2024
- Initiation Date
- September 24, 2024
- Termination Date
- July 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2328 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: U24T0408A, Exp: 03/31/2026