Diabetes Drug Recalled for Microbial Contamination

Citing microbial contamination of the product, Sun Pharmaceutical Industries Inc is voluntarily recalling 13,834 bottles of Riomet (metformin hydrochloride oral solution), according to the April 21, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects cherry-flavored Riomet, 500 mg/5 mL, in 16-fluid ounce (473-mL) bottles (NDC 10631-206-02), from lots J190386A (Exp. 3/21), X190354A (Exp. 3/21), J190393A (Exp. 5/21), A200035A (Exp. 6/21), B200064A (Exp. 8/21), and H200236A (Exp. 1/22). The product was manufactured by Mikart LLC, Atlanta, GA, and distributed throughout the United States by Sun Pharmaceutical Industries. 

Sun Pharmaceutical Industries initiated the recall March 31, 2021. On April 13, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Riomet is a prescription drug used to control high blood sugar in patients with type 2 diabetes.

—Jolynn Tumolo