Granules India Recalls Over 2.3 Crore Ranitidine Tablets From U.S. Market
The tablets were distributed in Oregon, New York and New Jersey.
Drug firm Granules India is recalling over 2.3 crore ranitidine tablets, used to treat ulcers of the stomach and intestines, from the U.S. market, the latest report of the American health regulator said.
According to the Enforcement Report of the United States Food and Drug Administration, the company is recalling 2.3 crore Ranitidine tablets USP 150 mg, 10,000 count bag on account of "CGMP deviations: Impurity N-nitrosodimethylamine found in API".
CGMP refers to the Current Good Manufacturing Practice regulations. The voluntary ongoing recall is a class II recall, it added.
As per the U.S. FDA, a class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
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.