November 20, 2020
Two firms are recalling mesalamine delayed-release tablets after routine testing revealed out-of-specification dissolution results, according to the November 18, 2020, US Food and Drug Administration (FDA) Enforcement Report.
Teva Pharmaceuticals USA is recalling 133,829 bottles of mesalamine delayed-release tablets, 1.2 grams, 120 tablets per bottle (NDC 0591-2245-22), from lots 1342498A (Exp. 12/20); 1342499A (Exp. 1/21); 1354638A (Exp. 3/21); 1354639A, 1358274A, 1358448A, 1364618A, and 1369884A (Exp. 5/21); 1366195A, 1369885A, and 1373570A (Exp. 6/21); 1373571A (Exp. 7/21); 1388571A (Exp. 1/22); 1395725A, 1396585A, 1397550A, and 1399389A (Exp. 4/22); and 1403885A and 1403886A (Exp. 6/22). The tablets were manufactured by Actavis Laboratories and distributed by Actavis Pharma in the United States and Puerto Rico.
AvKARE Inc. is recalling 15,678 bottles of mesalamine delayed-release tablets, 1.2 grams, 120 tablets per bottle (NDC 42291-564-12), from lots 26085 (Exp. 7/21), 26426 (Exp. 1/22), 26983 (Exp. 4/22), and 28647 (Exp. 6/22). The tablets were manufactured for AvKARE and distributed throughout the United States.
Both recalls were voluntarily initiated the last week of October 2020 and designated Class II by the FDA on November 6, 2020. 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 medication used to treat and prevent ulcerative colitis.