January 4, 2021

Nostrum Laboratories has expanded a recall of Metformin HCl Extended Release (ER) Tablets, USP 750mg, to include one additional lot. The affected product contains N-nitrosodimethylamine (NDMA) above the daily intake limit established by the FDA.

NDMA is a probable carcinogen (cancer-causing agent) and a known environmental contaminant found in water and food. It has been identified in several drug products, including certain metformin ER products, in recent years. As of the date of the recall expansion, Nostrum has not received any reports of adverse events related to NDMA found in the recalled product.

Metformin ER is indicated for use as an adjunct to diet and exercise to improve blood sugar control in adults who have type 2 diabetes mellitus. Because stopping the medication could be dangerous, the U.S. FDA recommends that patients speak with their healthcare provider before discontinuing the recalled product.

Consumers with medical questions regarding the recall can contact Nostrum Laboratories Medical Affairs at 1- 816-308-4941 or send an email to quality@nostrumpharma.com. Adverse events should be reported to the patient’s healthcare provider and can also be reported to the FDA’s MedWatch program.

A full copy of the recall announcement can be found on the FDA’s website.

There is no member impact through Benecard Central Fill.

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