Microbial contamination: Sun Pharma recalls 2 lots of diabetes drug in US
New Delhi: Sun Pharma on Friday said its US-based subsidiary is recalling two lots of diabetes drug Riomet due to microbial contamination.
Sun Pharmaceutical Industries Inc (SPII), a wholly owned subsidiary of the company, is voluntarily recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), 500 mg/5mL to the retail level, the Mumbai-based drug major said in a statement.
The product is manufactured for SPII by a contract manufacturer, it added.
The Riomet has been found to be contaminated with the microbe, 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, Sun Pharma said.
Use of contaminated Riomet potentially could result in a risk of infection, especially in the immunocompromised patient.
"To date, SPII has not received any reports of adverse events related to this recall," the company said.
Riomet is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above.