Production & Manufacturing

Microbial contamination forces Sun Pharma to recall two lots of diabetes drug in US

PBR Staff Writer Published 27 November 2017

Sun Pharmaceutical Industries is voluntarily recalling two lots of diabetes drug Riomet in the US due to microbial contamination.

Riomet was approved in the US for the treatment of type 2 diabetes mellitus in adult and children age 10 and above. The diabetes oral solution is manufactured in 118mL (4fl. oz.) and 473mL (16fl. oz.) bottles.

Sun Pharmaceutical says that the product was manufactured on its behalf by a contract manufacturer and the recall to the retail level comes under a Class II case.

Riomet has been found to have been contaminated with a microbe named Scopulariopsis brevicaulis.

The issue was identified at the time of sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) which was carried out as part of the 12-month stability study interval.

The recalled Riomet lots bear NDC Code 10631-206-01 Lot A160031A and NDC 10631-206-02 with both having expiry dates of 01/2018. The contaminated product was distributed across the US to wholesale customers.

According to the pharma company, taking the contaminated Riomet solution could potentially lead to infection, particularly in the immunocompromised patient

It further added that the most probable portal of entry of Scopulariopsis brevicaulis is the respiratory tract. Once the microbial enters the body, it could lead to pneumonia, sinusitis and disseminated infections.

The company says that as of now it hasn’t got any reports of adverse incidents associated to the recall of Riomet.

Sun Pharmaceutical has warned consumers who have the recalled diabetes medicine to stop using it and either return it to where they had bought or discard it. It has also advised them to contact their doctor if needed.

Image: Sun Pharmaceutical’s Riomet (Metformin Hydrochloride Oral Solution). Photo: courtesy of Sun Pharmaceutical Industries Ltd.