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 drug.safetyUSA@sunpharma.com.
Several companies have recently initiated recalls of their metformin extended-release (ER) products due to the possibility of unacceptable levels of NDMA. The FDA has published a recalled metformin list that includes the NDC Number, Lot Number, and Expiration Date for all affected products.
According to the Agency, patients who take a drug that contains nitrosamine impurities at or below acceptable daily intake levels are not expected to be at an increased risk of cancer, even if the drug is ingested daily for 70 years. However, the risk may be increased in individuals who are exposed to these genotoxic substances above acceptable levels and for long periods of time.
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. https://www.businesswire.com/news/home/20200923005168/en/Sun-Pharmaceutical-Industries-Inc.-Issues-Voluntary-Nationwide-Recall-of-RIOMET-ER%E2%84%A2-metformin-hydrochloride-for-extended-release-oral-suspension-Due-to-N-Nitrosodimethylamine-NDMA-Content-Above-the-Acceptable-Daily-Intake-ADI-Limit. Accessed September 23, 2020.