Granules Pharmaceuticals, Inc. Recalls its 750 mg Extended-Release Tablet of USP Metformin Hydrochloride (Metformin) Due to NDMA Carcinogen Contamination
WASHINGTON, D.C. — The U.S. Food and Drug Administration, FDA, announced that the prescription drug maker Granules Pharmaceuticals, Inc. issued a voluntary recall for its 750 mg extended-release tablet of USP Metformin Hydrochloride (Metformin). According to a company announcement published by the FDA, Granules Pharmaceuticals, Inc. recalled its Metformin drug because the company detected NDMA (N-Nitrosodimethylamine) in its medication that surpasses the daily amount of NDMA the FDA allows Americans to consume daily. The company recalled twelve lots of its Metformin 750 in 100- and 500-count bottles. Granules Pharmaceuticals, Inc. said that there are no adverse reactions or illnesses linked to the recalled medication. The company also said that its Metformin immediate-release tablets in 500, 850, and 1,000 mg doses are unaffected by this voluntary recall.
Granules Pharmaceuticals, Inc. conducted tests on its Metformin medications. The drug maker found that one of the twelve lots manufactured at the same time contained potentially dangerous levels of NDMA. Consequently, Granules Pharmaceuticals, Inc. determined the safest course of action was to remove all twelve of the lots manufactured at the same time from the market voluntarily. None of Granules Pharmaceuticals’ Metformin medications are affected by the present recall program.
NDMA is a chemical substance that is probably a carcinogen. Laboratory tests indicate that NDMA could cause cancer in humans. Therefore, the FDA established a maximum limit on the amount of NDMA a person should consume daily. NDMA is found in many American food sources such as drinking water, vegetables, meat, and dairy goods. The presence of NDMA in Metformin, if the contaminated lots were allowed to remain available for consumption, would cause people to ingest NDMA at a daily level determined to be safe.
The recall campaign affects patients who take Metformin daily. Individuals who use Metformin must contact their physicians to discuss whether alternative medications should be prescribed. Any person who has any amount of the recalled medication must return it to the pharmacy from which it was purchased or contact Granules Pharmaceuticals, Inc.
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