Sun Pharma announced the voluntary recall of 1 lot of Riomet ER™ (metformin HCl for extended-release oral suspension) 500mg/5mL as the product contains a level of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake limit established by the Food and Drug Administration (FDA).

Riomet ER is 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. The recalled product, Riomet ER 500mg/5mL; NDC# 10631-019-17; Lot Number AB06381; Expiry Date 10/2021, was distributed nationwide to wholesale customers.

Sun Pharma is notifying its distributors and customers to arrange the return of all recalled products. Distributors and retailers should halt distribution and return any recalled products as directed in the recall notification. Patients should continue taking Riomet ER until advised by their health care provider regarding an alternative treatment.

Any adverse events associated with the recall should be reported to the FDA’s MedWatch program. For more information regarding this recall contact Sun Pharma by calling (800) 818-4555 or emailing [email protected]

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Sun Pharmaceutical Industries, Inc. issues voluntary nationwide recall of Riomet ER™ (metformin hydrochloride for extended-release oral suspension) due to N-Nitrosodimethylamine (NDMA) content above the acceptable daily intake (ADI) limit. Accessed September 23, 2020.