Nearly 30,000 Bottles of a Statin Recalled

Nearly 30,000 bottles of 10-mg atorvastatin calcium tablets are being recalled by Graviti Pharmaceuticals after a customer reported finding a 20-mg tablet in a bottle, according to the  February 12, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall includes 90-count bottles of atorvastatin calcium tablets, 10 mg (NDC 70377-027-11), from lot ATA318099C (Exp. 12/20). The tablets were manufactured by Graviti Pharmaceuticals for Biocon Pharma and distributed throughout the United States.  

Graviti Pharmaceuticals voluntarily initiated the recall January 28, 2020. On February 7, 2020, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Atorvastatin is a prescription medication used to treat high cholesterol.

—Jolynn Tumolo