Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall).
This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis).
The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.
Use of Riomet (Metformin Hydrochloride Oral Solution) potentially could result in a risk of infection, especially in the immunocompromised patient.
Riomet (Metformin Hydrochloride Oral Solution) is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above. Riomet is packaged in 118 mL (4 fl. oz.) and 473 mL (16 fl. oz.) bottles.