Nivagen Pharmaceuticals Inc recalls Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, I…

Recall date

September 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0001-2025

FDA classification

Class II

Brand / firm

Nivagen Pharmaceuticals Inc

Sold / distributed

Nationwide within the U.S

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.