Apotex Corp. is recalling all lots of Metformin Hydrochloride Extended-Release tablets after Food and Drug Administration (FDA) testing revealed that one lot contained unsafe levels of N-Notrosodimethylamine, or NDMA, a probable human carcinogen.
Apotex stopped selling the product in the United States in February 2019, and there remains only limited product on the market, the drug company said.
Metformin is a prescription medication used to manage blood sugar levels in adults and pediatric patients with type 2 diabetes. Apotex’s recall involves Metformin Hydrochloride Extended-Release Tablets, 500 mg, in 100-count bottles with the NDC Number 60505-0260-1.
NDMA is a known environmental contaminant that is often found in food and water. Human consumption of the impurity is not unusual, but the FDA sets a limit of 96 nanograms as safe for daily consumption. “Sustained higher levels may increase the risk of cancer in humans,” the FDA noted.
On Sept. 25, 2019, Apotex became one of dozens of companies to issue recalls of ranitidine tablets, the active ingredient in the heartburn drug Zantac, after testing revealed the drugs contained elevated levels of NDMA. On April 1, 2020, the FDA announced it was pulling all Zantac products from the market after further testing revealed levels of NDMA could increase to unsafe levels even under normal storage conditions.
Apotex’s metformin recall announcement comes at the same time the FDA issued a news release alerting the public that testing on metformin ER products revealed several had elevated levels of NDMA. The FDA said it is encouraging five firms to recall their products. Testing on more extended-release version of metformin continue.
Beasley Allen attorneys Frank Woodson and Lisa Courson are 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.