"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.
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.
“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. Glenmark is notifying its direct customers by mailing a recall notification letter and is arranging for return of all recalled products. Anyone with an existing inventory of the product should quarantine the recalled lot immediately, it added.
“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.
Ranitidine tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.