March 13, 2020
Teva Pharmaceuticals USA is recalling nearly 3700 bottles of mesalamine delayed-release tablets distributed throughout the United States by Actavis Pharma, Inc. According to the March 11, 2020, US Food and Drug Administration (FDA) Enforcement Report, samples of the drug failed to meet dissolution specifications during routine stability testing.
The recall affects 120-count bottles of mesalamine delayed-release tablets, 1.2 grams (NDC 0591-2245-22), from lot 1342500A (Exp. 10/20).
Teva Pharmaceuticals voluntarily initiated the recall February 20, 2020. On March 2, 2020, the FDA designated the recall Class II. 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.
Mesalamine is a prescription nonsteroidal anti-inflammatory drug used to treat ulcerative colitis and to prevent ulcerative colitis flare-ups.