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- Tags: Apotex, cancer, Carcinogen, contaminant, Marksans Pharma, metformin, NDMA, Recall, Teva
Metformin Hydrochloride: Recalled
Lupin Pharmaceuticals is recalling lot G901203 of Metformin Hydrochloride Extended-Release Tablets (generic equivalent of Fortamet), USP 500 mg. Image of packaging label below.
Teva is adding their 500/750mg tablets to the recall list. Image of packaging below. Marksans Pharma is recalling Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, lot # XP9004, image also below.
Metformin Hydrochloride Extended-Release Tablets 500 mg by Apotex are being recalled due to the detection of N-Nitrosodimethylamine (NDMA). If you remember, this is the same reason for the recall of the heart burn medication Ranitidine, or Zantac.
Apotex is recalling all lots of Metformin Hydrochloride Extended-Release tablets 500 mg (Lots identified in table below) out of abundance of caution after one lot was tested by the FDA and showed N-Nitrosodimethylamine (NDMA) concentrations exceeding the levels established by the FDA. NDMA is classified as a potential human carcinogen and environmental contaminant of foods.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Metformin Hydrochloride Extended-Release Tablets, is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
–MedWatch – The FDA Safety Information and Adverse Event Reporting Program