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Drug Manufacturer Pulls Metformin Drug From Market After Contamination with NDMA


July 14, 2020

WASHINGTON, D.C. — Another American drug company removed one of its Metformin drugs after testing revealed the presence of a possible carcinogen. Granules Pharmaceuticals, Inc., recalled twelve lots of its Metformin Hydrochloride Extended-Release USP 750 mg tablets after in-house testing determined that one of the batches contained N-Nitrosodimethylamine, or NDMA, which is a suspected carcinogen. Although only one lot out of the twelve tested positive for the potentially cancer-causing agent, Granules Pharmaceuticals, Inc., determined the safest course of action dictated instituting a recall of all twelve lots. The U.S. Food and Drug Administration (FDA) announced that Granules Pharmaceuticals, Inc. voluntarily initiated the recall campaign. 

Granules Pharmaceuticals, Inc., which has headquarters in Chantilly, Virginia, informed the FDA and the public that its Metformin Hydrochloride Extended-Release Tablets USP, in 750 mg doses must be recalled. The recalled medication was distributed in 100-count bottles and 500-count bottles. The FDA described the recall as “to the consumer level,” which means that some of the recalled medication might now be in the hands of patients. However, Granules Pharmaceuticals, Inc. said that its Metformin distributed in doses of 500 mg, 850 mg, and 1000 mg are not subject to recall. The company did not say why the only affected dose was 750 mg. 

The FDA classifies NDMA as a potential human carcinogen based on laboratory results. The substance is known to be found in the environment generally and in certain items consumed by people in America daily, such as drinking water, dairy products, meat, and some vegetables. Federal regulators established a limit on the amount of NDMA a person could consume daily due to the chemical contaminates. 

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Source:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended

Category: Product Liability

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