FDA recall D-0001-2025

Nivagen Pharmaceuticals Inc · Class II · drug

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.

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.

Distribution

Nationwide within the U.S

Key facts

Status
Ongoing
Initiation date
2024-09-24
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sacramento, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2025