Nivagen Pharmaceuticals Inc: Drug Recall
Recall #D-0001-2025 · 09/24/2024
Class II: Risk
Recall Details
- Recall Number
- D-0001-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Nivagen Pharmaceuticals Inc
- Status
- Ongoing
- Date Initiated
- 09/24/2024
- Location
- Sacramento, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2328 bottles
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.
Distribution Pattern
Nationwide within the U.S
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.