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.
Reported: October 9, 2024 Initiated: September 24, 2024 #D-0001-2025
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.
Details
- Recalling Firm
- Nivagen Pharmaceuticals Inc
- Units Affected
- 2328 bottles
- Distribution
- Nationwide within the U.S
- Location
- Sacramento, CA
Frequently Asked Questions
What product 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.. Recalled by Nivagen Pharmaceuticals Inc. Units affected: 2328 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2024. Severity: Moderate. Recall number: D-0001-2025.
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