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Cancer-Causing Agent Found in Metformin Forces Recall


July 13, 2020

WASHINGTON, D.C. — Another major drug company has announced a voluntary recall of a Metformin drug after analysis revealed the presence of a cancer-causing contaminant. Granules Pharmaceuticals, Inc., notified the U.S. Food and Drug Administration (FDA) that it would voluntarily recall twelve batches of its Metformin Extended-Release USP 750 mg tablets due to the presence of N-Nitrosodimethylamine, or NDMA, in recent quality control analysis. Granules Pharmaceuticals, Inc., said that only one batch out of the twelve tested at the same time contained the carcinogenic agent. Notwithstanding, the drugmaker decided that recalling the drugs voluntarily was the most prudent measure, according to a company announcement reproduced by the FDA. Granules Pharmaceuticals, Inc. said that it had not received any reports of injuries or illnesses from the contamination. 

The recall program initiated by Granules Pharmaceuticals, Inc. included distributors, hospitals, doctors, and patients. Granules Pharmaceuticals, Inc. reported that one of the twelve batches of Metformin Hydrochloride Extended-Release Tablets USP, in 750 mg doses tested positive for the presence of NDMA. As a consequence of the test results, the company determined that a person would exceed the daily-allowable dose of NDMA if allowed to take the medication. 

Although NDMA can be found in drinking water, meat, dairy, and vegetables consumed by people in the United States, the FDA determined that any amount of NDMA that exceeds that allowable daily dose could cause cancer. At this time, the evidence that NDMA is a carcinogen has only been replicated in a laboratory. However, the link between NDMA consumption and cancer is sufficiently strong to require drug companies like Granules Pharmaceuticals, Inc. to recall any medication in which NDMA levels exceed daily consumption limits. 

Granules Pharmaceuticals, Inc. arranged for distributors, pharmacies, and hospitals to quarantine the recalled Metformin doses from non-contaminated medications. The drugmaker will arrange to have these institutions return the medication to the company. Individual patients should discard the medication or return it to the pharmacy. The FDA advised that no one should change medication without first talking with a physician.

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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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