Sun Pharmaceutical Industries, Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd., on Wednesday recalled one lot of type 2 diabetes medication RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL.
The recall is due to the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI) established by the U.S. Food and Drug Administration.
SUN PHARMA has not received any reports of adverse events related to this recall to date. The product was distributed across the U.S. to wholesale customers and the company will arrange for return of all recalled products.
Distributors and retailers that have RIOMET ER, which is being recalled, should stop distributing and return it to place of purchase or as directed in the recall notification.
The company urged patients taking RIOMET ER to continue taking their medication and contact their medical provider for advice regarding an alternative treatment.
NDMA, a known environmental contaminant, is classified as a probable human carcinogen that could cause cancer. This is generally found in water and foods, including meats, dairy products, and vegetables.
RIOMET ER is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
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