Sun Pharmaceutical Recalls Riomet

Published on: 

The company is recalling product because of microbial contamination.

Sun Pharmaceutical Industries, Inc. announced on Nov. 24, 2017 that it was voluntarily recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), 500 mg/5mL because Scopulariopsis brevicaulis was found during testing. The recalled lots were manufactured by a contract manufacturer. The company discovered the contamination during sample preparation for the antimicrobial preservative effectiveness testing, which was performed as part of the 12-month stability study interval.

Riomet is used to treat type 2 diabetes mellitus in adults and children over 10. While the company has not yet received any complaints of adverse events, use of contaminated product could cause infection, pneumonia, and sinusitis.

The recalled lots are NDC Code 10631-206-01 Lot A160031A, with an expiration date of 01/2018, and NDC 10631-206-02 Lot: A160031B, with an expiration date of 01/2018. The lots were distributed nationwide to wholesale customers.


Source: FDA