Class II
Ongoing
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.
This recall is currently active, issued October 9, 2024. It was issued by Nivagen Pharmaceuticals Inc.
- Company
- Nivagen Pharmaceuticals Inc
- Recall Initiated
- September 24, 2024
- Posted
- October 9, 2024
- Recall Number
- D-0001-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2328 bottles
- Firm Location
- Sacramento, CA, United States
- Official Source
- View on FDA website ↗
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
Nationwide within the U.S
Lot / Code Info
Lot #: U24T0408A, Exp: 03/31/2026
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