September 23, 2020

Sun Pharmaceuticals has issued a voluntary recall of one lot of Riomet ER™ (metformin hydrochloride for extended-release oral suspension), 500mg/5mL. The affected product may contain N-nitrosodimethylamine (NDMA) above the daily intake limit established by the U.S. FDA.

NDMA is a probable human carcinogen (cancer-causing agent) that has been identified in several metformin ER products, as all as in ranitidine and certain “sartan” products. It is also a known environmental contaminant found in water and food.

Riomet ER is a brand-name prescription oral medication indicated as an adjunct to diet and exercise to improve blood sugar control in patients at least 10 years of age who have type 2 diabetes mellitus. As of the date of the recall, Sun Pharmaceuticals has not received any reports of adverse events related to the affected product.

According to the FDA, patients currently on Riomet ER should continue taking their medication and contact their healthcare provider or pharmacist for advice regarding an alternative treatment. The risk of stopping the medication could outweigh the potential risk of NDMA exposure. Patients can contact Sun Pharmaceuticals by phone at 1-800-818-4555 or by email at drug.safetyUSA@sunpharma.com with questions regarding the recall. If a patient has experienced any adverse events that may be related to use of the recalled product, they should contact their healthcare provider. Adverse events can also be reported to the FDA’s MedWatch program.

Additional recall details are available in a press release from the manufacturer.

There is no member impact through Benecard Central Fill.

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