You are here: Home » Companies » News
Business Standard

Sun Pharma recalls diabetes drug in US over microbial contamination

Use of contaminated Riomet potentially could result in a risk of infection, especially in the immunocompromised patient.

Press Trust of India  |  New Delhi 

medicine, drug, antibiotic, doctor, pharmaceuticals

Sun Pharma today said its US- based subsidiary is recalling two lots of due to

Industries Inc (SPII), a wholly owned subsidiary of the company, is voluntarily recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), 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 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.

First Published: Fri, November 24 2017. 20:35 IST
RECOMMENDED FOR YOU