Sun Pharma Recalls 1 Lot of Metformin Due to NDMA Levels

Sun Pharmaceuticals announced it is voluntarily recalling 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL to the consumer level, according to a company statement.

Sun Pharmaceuticals announced it is voluntarily recalling 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL to the consumer level, according to a company statement.

The recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake limit established by the FDA.

When reconstituted, metformin hydrochloride for ER oral suspension is packaged in a 16 oz (473 mL) round bottle. Each carton contains 1 bottle of drug pellets, 1 bottle of diluent, and 1 dosing up. The products can be identified by the bottles or carton labeled with the lot number AB06381, with an expiration date of October 2021.

Sun Pharmaceuticals is notifying its distributors and customers through its third-party Recall Coordinator, via FedEx standard overnight shipping, and will arrange for return of all recalled products.

Patients taking metformin hydrochloride for ER oral suspension, 500 mg per 5 mL, are advised to continue taking their medication and contact their pharmacist, physician, or medial provider for advice regarding an alternative treatment.

The FDA published a recalled metformin list including details about metformin products that have been recalled. According to the FDA, its testing has not shown NDMA in immediate-release metformin products.

Reference

1. Sun Pharmaceuticals 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. Company announcement. FDA; September 23, 2020. Accessed September 24, 2020. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sun-pharmaceutical-industries-inc-issues-voluntary-nationwide-recall-riomet-ertm-metformin?utm_medium=email&utm_source=govdelivery​