- The tablets have presence or potential presence of NDMA levels above the acceptable daily intake levels
- Affected ranitidine tablets were distributed directly to wholesalers, distributors, retailers and repackagers nationwide
Drug firm Glenmark Pharmaceutical Inc, USA said it is voluntarily recalling all unexpired lots of its ranitidine tablets, used to treat ulcers of the stomach and intestines, from the US market.
The tablets are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the United States Food and Drug Administration (USFDA), as per the company’s announcement posted on the website of the US health regulator.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer). It is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables, it said.
The company said it has not received any reports of adverse events that have been confirmed to be directly related to this recall.