FDA Recalls Pravastatin Sodium Tablets

A foreign tablet found in a bottle of pravastatin sodium tablets, 20 mg, has prompted Glenmark Pharmaceuticals Inc. to issue a recall for the remainder of the lot, according to the April 17, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The firm is recalling 500-count bottles of pravastatin sodium tablets, 20 mg (NDC 68462-196-05), from lot 17181491 (Exp. 8/21). The 2076 bottles included in the recall were distributed throughout the United States.

Glenmark Pharmaceuticals voluntarily issued the recall March 25, 2019. On April 11, 2019, the FDA designated it a Class II recall. 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.

Pravastatin is a prescription medication used to treat patients with high cholesterol and triglyceride levels. 

—Jolynn Tumolo