Recalls / Class II
Class IID-0001-2025
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.
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin
- Route
- Oral
- NDCs
- 75834-255, 75834-256, 75834-257, 75834-258
- FDA application
- ANDA213853
- Affected lot / code info
- Lot #: U24T0408A, Exp: 03/31/2026
Why it was recalled
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.
Recalling firm
- Firm
- Nivagen Pharmaceuticals Inc
- Manufacturer
- NIVAGEN PHARMACEUTICALS, INC.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 3100 Fite Cir, N/A, Sacramento, California 95827-1805
Distribution
- Quantity
- 2328 bottles
- Distribution pattern
- Nationwide within the U.S
Timeline
- Recall initiated
- 2024-09-24
- FDA classified
- 2024-10-02
- Posted by FDA
- 2024-10-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0001-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.