Recalling firm
Nivagen Pharmaceuticals Inc
Product type
Drug
Status
Terminated
Report date
2024-10-09
Distribution
Nationwide within the U.S
Firm state
CA
Product quantity
2328 bottles
Initiated by
Voluntary: Firm initiated
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.
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.
Code / lot info
Lot #: U24T0408A, Exp: 03/31/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.