January 09, 2020
Two more firms have announced voluntary recalls of ranitidine products due to contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA). The recalls, from American Health Packaging and Granules India Limited, were included in the January 8, 2020, US Food and Drug Administration (FDA) Enforcement Report.
American Health Packaging is recalling prescription ranitidine syrup (ranitidine oral solution), 15 mg/mL, 150 mg/10 mL per cup. The recall includes the following, which were distributed throughout the United States:
- 50-cup cases (NDC 60687-260-69) from lots 177874 (Exp. 1/31/20), 178413 (Exp. 2/29/20), 183449 (Exp. 10/31/20), 184445 (Exp. 12/31/20), 186563 (Exp. 3/31/21), and 187691 (Exp. 5/31/21); and
- 40-cup cases (NDC 60687-260-23) from lots 183723 (Exp. 10/31/20), 184278 (Exp. 10/31/20), and 187652 (Exp. 5/31/21).
Granules India Limited is recalling over-the-counter ranitidine tablets, 150 mg, 10,000-count bags (NDC 62207-773-32) from lots 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A, and 7730012A. The tablets were distributed in Oregon, New York, and New Jersey.
The recalls were initiated by American Health Packaging on November 1, 2019, and by Granules India Limited on December 13, 2019. On December 29, 2019, the FDA designated them Class II, communicating use of the products could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Over-the-counter ranitidine is used to prevent and treat heartburn. Prescription ranitidine is used in the treatment of ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid.