Statin Recalled for Containing Anticonvulsant

Nivagen Pharmaceuticals Inc. is recalling 2328 bottles of atorvastatin calcium tablets. According to the October 9, 2024, US Food and Drug Administration (FDA) Enforcement Report, the recall was initiated after a 400-mg carbamazepine extended-release tablet was found in a bottle.

The recall affects 1000-count bottles of atorvastatin calcium tablets, 40 mg (NDC 75834-257-01), from lot  U24T0408A (Exp. 3/31/26). The drug was manufactured by Umedica Laboratories Pvt Ltd., Vapi, Gujarat, India, for Nivagen Pharmaceuticals, Sacramento, California, and was distributed within the United States. 
Nivagen Pharmaceuticals initiated the recall on September 24, 2024. The FDA designated the recall Class II on October 2, 2024. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Atorvastatin is a prescription statin used to treat numerous conditions, including high cholesterol, hyperlipidemia, coronary artery disease, peripheral artery disease, stroke, atherosclerosis, acute coronary syndrome, transient ischemic attack, and heart attack.