Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Niva...
FDA Recall #D-0001-2025 — Class II — September 24, 2024
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.
Recalling Firm
Nivagen Pharmaceuticals Inc — Sacramento, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2328 bottles
Distribution
Nationwide within the U.S
Code Information
Lot #: U24T0408A, Exp: 03/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated