Sun Pharmaceuticals Industries Inc., (Sun Pharma) is recalling one lot of Riomet ER, an extended-release version of the type 2 diabetes drug metformin because it contains unsafe levels of a probable cancer-causing impurity known as NDMA, short for N-nitrosodimethylamine, the Food and Drug Administration (FDA) announced.
The recall involves Riomet ER, 500 mg per 5mL, with the lot number AB06381, NDC Number 10631-019-17, and expiration date 10/2021. Consumers who have this product are advised to continue taking it and contact their pharmacist, doctor, or medical provider for an alternative treatment, as it could be dangerous for patients with diabetes to stop taking their medication without first talking with a health care professional.
Consumers with questions regarding the recall of Riomet ER can contact Sun PHarma by calling 1-800-818-4555 or e-mailing drug.safetyUSA@sunpharma.com.
Riomet ER is one of several extended-release formulations of metformin that have been recalled over health concerns due to elevated levels of NDMA. The impurity is an environmental contaminant that is found in some food and drinking water. The FDA has established that consuming up to 96 nanograms of NDMA daily is reasonably safe based on lifetime exposure. But, “sustained higher levels of exposure may increase the risk of cancer in humans.”
NDMA has been detected in the high blood pressure and heart failure drug Valisure and similar products in the ARB family of drugs. More recently, unsafe levels of NDMA have been found in the heartburn drug Zantac and other medications containing ranitidine. In April, the FDA removed Zantac from the U.S. market due to safety concerns.
Attorneys with Beasley Allen Law Firm are currently investigating claims of those who have used Zantac, which was voluntarily recalled from the market on Sept. 13, 2019, and withdrawn on April 1, and has been linked to certain types of cancer, including liver, bladder, stomach, colon, kidney and pancreatic cancer. If you or a loved one was a regular user of Zantac or any other product containing ranitidine and have been diagnosed with cancer, we would like to talk with you. Contact Frank Woodson, one of our leading pharmaceutical attorneys in charge of Zantac cancer claims. We are not currently handling cases involving NDMA in metformin.