Amneal Pharmaceuticals has announced a voluntary recall for both ranitidine tablets and ranitidine syrup because of potential N-nitrosodimethylamine (NDMA) levels above Food and Drug Administration–allowed cutoffs, according to an FDA MedWatch alert.
NDMA, a probable human carcinogen, has been found in several different ranitidine products since an initial FDAin September 2019. Ranitidine, a histamine2 receptor blocker, is indicated for multiple conditions, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
The affected ranitidine products being recalled by Amneal include 60-, 100-, 180-, 500-, and 1,000-count 150-mg tablets; 30-, 100-, 250-, and 1,000-count 300-mg tablets, and a 15-mg/mL syrup. The manufacturer has not received any reports of adverse events confirmed to be directly related to the recall.
Consumers should contact their physicians or health care providers if they have experienced any problems that may be related to the use of this drug product, the FDA said. Adverse reactions or quality problems can be reported to Amneal Drug Safety by phone at 1-877-835-5472.