Drug firm Glenmark Pharmaceutical Inc, USA, is voluntarily recalling all unexpired lots of its ranitidine tablets, used to treat ulcers of the stomach and intestines, from the US market, the company announced recently.
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, as per a PTI report.
“Glenmark will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers,” the announcement said.
“As a further precautionary measure, Glenmark ceased distribution of its ranitidine products in the United States while it continues its efforts to test and investigate in cooperation with the FDA,” it added.
The affected ranitidine tablets were distributed directly to wholesalers, distributors, retailers and repackagers nationwide.
“Consumers who have ranitidine tablets, USP subject to this recall should immediately discontinue use and consult with their physician or healthcare provider about treatment options,” it said.
“Glenmark’s Ranitidine tablets 150 mg and 300 mg are manufactured at two approved manufacturing facilities. Of the 928 recalled lots of ranitidine tablets, USP, 16 lots were manufactured by Glenmark Pharmaceuticals Ltd, Goa, and 912 lots were manufactured by Strides Pharma Science Ltd, Puducherry,” it said.