Reported Oct 9, 2024 · Terminated
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals,…
Nivagen Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nivagen Pharmaceuticals Inc · 3100 Fite Cir · Sacramento, CA · 95827-1805
Is this the product you have?
- Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle
- Manufactured forNivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA
- Manufactured byUmedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India
- NDC75834-257-01
- Lot codes and dates
- Lot #: U24T0408A
- Exp03/31/2026
- Amount recalled
- 2328 bottles
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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