Bayshore Pharmaceuticals is recalling some extended-release versions of the type 2 diabetes drug metformin because it was found to contain unsafe levels of a potential cancer-causing contaminant called NDMA (N-Nitrosodimethylamine).
The recall involves one lot of 500mg, 1,000-count bottles of Metformin Hydrochloride Extended-Release Tablets, and one lot of 750mg, 100-count bottles of the drug. The product was manufactured by Beximco Pharmaceuticals Limited based in Dhaka, Bangladesh in June 2019, and distributed in the U.S. by Bayshore.
Metformin Hydrochloride Extended-Release Tablets are used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Anyone who has recalled versions of the medication should contact their pharmacist, physician or medical provider for advice.
In May, the FDA issued a safety announcement informing the public that testing had revealed NDMA at unsafe levels in several different brands of extended-release metformin products. Several of the drugs have since been recalled.
NDMA is classified as a probable human carcinogen based on laboratory testing. It is a known environmental contaminant found in water and foods. The FDA considers 96 nanograms of NDMA a day reasonably safe to humans based on lifetime exposure but levels higher pose cancer risks
NDMA is the same cancer-causing impurity that was identified last fall in dangerously high levels in the heartburn drug Zantac, known generically as ranitidine. Several Zantac products were recalled and, on April 1, the Food and Drug Administration (FDA) ordered the removal of all Zantac products from the U.S. market due to the public health risks.
Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, or pancreas. If you or a loved one may have been affected, please contact us. Beasley Allen is not currently taking claims related to metformin.