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Metformin E.R. Recalled by Several Companies Because of Possible NDMA Contamination

July 20, 2020

WASHINGTON, D.C. — Several pharmaceutical companies have recalled Metformin E.R., or extended-release tablets, because the medication may contain elevated levels of N-Nitrosodimethylamine (NDMA). NDMA is a suspected human carcinogen. The U.S. Food and Drug Administration (FDA) recently published a comprehensive list of metformin drugs pulled from the U.S. market. The FDA provided the recalled medication’s NDC number, lot numbers, and expiration dates, according to an article published on the MPR website. The FDA proclaimed that people who take metformin could ingest elevated levels of NDMA, which, in turn, could place the patient at risk for developing cancer because taking the contaminated medication could exceed the daily-allowable dose of NDMA. 

The FDA permits people to consume a certain amount of NDMA daily. NDMA is found in a large number of the foods that people who live in the United States consume every day. People ingest NDMA when eating meats, dairy products, water, and some vegetables. The FDA speculates that taking medicine or consuming another substances that contains NDMA, could place the patient in danger of developing cancer if the NDMA consumption exceeds the daily recommended doses for an extended time. The FDA states that people who take NDMA doses below the recommended daily allowance for even 70 years at not at risk for developing cancer. The FDA reiterated that NDMA was linked to cancer through laboratory testing. 

Extended-release Metformin medications exclusively are under recall. Conversely, immediate-release Metformin medications are NDMA-free and are not subject to recall. 

Metformin is a drug designed to combat type-2 diabetes. Exercise and diet coupled with a metformin regimen work to decrease insulin sensitivity.  People who take metformin should speak with their physicians about alternatives to metformin before stopping the medication of their own accord. 

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Category: Product Liability

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.