FDAHealthSeptember 24, 2024

Nivagen Pharmaceuticals Inc — Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Ume

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: September 24, 2024

Nationwide within the U.S

What's affected?

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: ATORVASTATIN CALCIUM
UPC: 0375834258027
Lot code: U24T0408A

Additional details

Lot #: U24T0408A, Exp: 03/31/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2328 bottles.

View original FDA notice →

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