FDA-Drug2024-10-09Class II
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.
Nivagen Pharmaceuticals Inc
Hazard
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.
Sold states
Nationwide within the U.S
Affected count
2328 bottles
Manufactured in
3100 Fite Cir, N/A, Sacramento, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2025Don't want to check this manually?
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