October 16, 2020
Direct Rx is recalling ranitidine tablets distributed in two states because of potential contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA), according to the October 14, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following prescription-strength ranitidine products, which Direct Rx packaged and distributed in Florida and Georgia:
- ranitidine, 150 mg, 60-tablet bottles (NDC 61919-339-60) from lot 09AU1911 (Exp. 2/28/22);
- ranitidine, 150 mg, 90-tablet bottles (NDC 61919-339-90), from lot 09SE1904 (Exp. 3/31/22); and
- ranitidine, 300 mg, 30-tablet bottles (NDC 61919-455-30), from lot 29JA1915 (Exp. 9/30/21).
Direct Rx voluntarily initiated the recall January 15, 2020. The FDA, on October 5, 2020, 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.
Prescription-strength ranitidine is used to treat ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid.