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Diabetes Drug Recalled for Microbial Contamination
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