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According to the Enforcement Report of the United States Food and Drug Administration (USFDA), the company is recalling 23,090,000 Ranitidine tablets USP 150mg, 10,000 count bag on account of “CGMP deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.”
CGMP refers to the Current Good Manufacturing Practice regulations.
The voluntary ongoing recall is a class II recall, it added.
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The tablets were distributed in Oregon, New York and New Jersey, the report said.
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.