Metformin Recall Issued By Bayshore Pharmaceuticals Due To High Levels Of NDMA

Amid the continuing discovery of problems with metformin pills contaminated with cancer-causing chemicals, federal regulators have announced another major recall for the generic diabetes drug, due to the presence of high levels of N-nitrosodimethylamine (NDMA) in pulls manufactured and sold by Bayshore Pharmaceuticals.

The FDA announced the latest metformin recall on August 20, following the detection of NDMA in Bayshore 500 mg and 750 mg extended release tablets.

NDMA is considered a human carcinogen, which can be a byproduct of the drug manufacturing process or from inherent processes associated with certain pharmaceutical ingredients.

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In recent years, detection of the chemical has resulted in widespread Zantac recalls and valsartan recalls, and users of the popular heartburn and blood pressure medications have reported developing various types of cancer following long-term use, including breast cancer, bladder cancer, stomach cancer, testicular cancer and other injuries.

This latest recall affects two lots of generic metformin distributed by Bayshore Pharmaceuticals, including Metformin Hydrocholoride Extended-Release Tablets USP in 500 mg strength, sold in 1,000-count bottles with a lot number of 18641 and an NDC Number of 76385-128-10; and Metformin Hydrochloride Extended-Release Tablets USP in 750 mg strength, sold in 100-count bottles with a lot number of 18657 and an NDC Number of 76385-129-01. Both lots have expiration dates of May 2021.

The pills were manufactured by Bexico Pharmaceuticals Limited, in Bangladesh in June 2019, and were distributed in the U.S. by Bayshore, who then sold the lots to wholesalers and distributors.

Metformin NDMA Problems

In December 2019, reports first warned about the potential risk of metformin NDMA contamination problems, after some versions of the drug sold outside the United States tested positive for the chemical, raising concerns that metformin recalls may be necessary. However, the FDA indicated at that time that testing of products distributed in the U.S. found that the NDMA levels in metformin were undetectable or below federal limits for exposure to the chemical.

In March 2020, the independent online pharmacy Valisure filed a citizen’s petition urging the FDA to recall metformin, after independent testing found levels of NDMA in certain pills was higher than the agency’s recommended daily exposure threshold of 96 nanograms.

Since then, the FDA says it has confirmed some of the Valisure findings, resulting in a number of separate recalls as specific lots of the medication have been found to contain higher than acceptable levels of NDMA.

Since the recalls began, a number of consumers have filed metformin NDMA lawsuits, indicating they developed cancer as a result of taking the tainted diabetes medication.

Bayshore indicates it is informing its customers of the recall by phone and through the recall notification. The company is currently arranging for the return of the recalled products and advises anyone with the affected lots quarantine them immediately.

Customers and patients with questions or who wish to report adverse events or quality issues can call Bayshore Pharmaceuticals LLC at 877-372-6093. Those wishing to return affected products can contact the company’s recall processor, Qualanex, LLC for instructions and a return kit by calling 888-504-2013.


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