FDA-Drug2024-10-09Class IIPROCESSING DEFECT
Nivagen Atorvastatin 40mg recalled for wrong tablet mixed in bottle
TAMPERINGNationwide distribution
Stop using Nivagen Atorvastatin 40mg tablets
A bottle of Nivagen Atorvastatin Calcium 40 mg tablets (lot U24T0408A) was found to contain a Carbamazepine 400 mg tablet—a different medication used for seizures and nerve pain. This happened during manufacturing and affects 2,328 bottles distributed nationwide. No injuries have been reported.
- Check if you have Atorvastatin lot U24T0408A (expiration 03/31/2026, NDC 75834-257-01).
- Do not take any tablets from an affected bottle without checking them first.
- Contact your pharmacy or doctor immediately if you took a tablet from this lot.
- Return the bottle to your pharmacy or contact Nivagen Pharmaceuticals for instructions on disposal or replacement.
Hazard
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.
Sold states
Nationwide within the U.S
Affected count
2328 bottles
Manufactured in
3100 Fite Cir, N/A, Sacramento, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2025Don't want to check this manually?
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