Consumer News

Drug Recall: Metformin Extended-Release, for Type 2 Diabetes

Sun Pharmaceutical Industries, Inc. has voluntarily recalled one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) due to the presence of an excessive amount of N-Nitrosodimethylamine (NDMA) in the product.

Only one lot is recalled, 500 mg per 5 mL:

  • Lot number: AB06381
  • NDC number: 10631-019-17
  • Expiration date: 10/2021

According to the recall, “The product can be identified by the bottles or carton labeled as RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), containing the specific Lot Number and Expiration Date referenced above or on the labeling below.  The product was distributed nationwide to wholesale customers.”

Sun Pharmaceuticals emphasizes that patients should not stop taking their medication without speaking with their healthcare provider or pharmacist, who will advise them regarding medication alternatives. “Consumers with questions regarding this recall can contact SUN PHARMA by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”

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