WASHINGTON (dpa-AFX) - Apotex Corp. recalled all lots of type 2 diabetes medication Metformin hydrochloride in the form of oral film-coated tablets for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.
The Weston, Florida-based generic and biodimilar pharma company is recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry, packaged in 100 count bottles.
Apotex agreed to extend the recall to all lots distributed in the U.S. out of an abundance of caution after the FDA notified it that one lot of Metformin HCL it tested showed NDMA levels in excess of the ADI. These were distributed across the U.S. to Warehousing Chains.
Apotex stopped selling this product in the U.S. in February 2019, and there remains only limited product on the market.
The company is yet to receive any adverse reports after using the recalled product.
The product is an oral antihyperglycemic drug used in the management of type 2 diabetes. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus, particularly in over weight patients.
NDMA, a known environmental contaminant, is classified as a probable human carcinogen that could cause cancer. This is generally found in water and foods, including meats, dairy products, and vegetables.
In September 2019, Apotex had recalled all pack sizes and formats of heartburn medication Ranitidine 75mg and 150mg in the form of tablets for the similar potential presence of NDMA, above levels established by the FDA.
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