Sun Pharma voluntarily recalls lots of Riomet due to microbial contamination

India’s Sun Pharmaceutical Industries (BSE: 524715) says that its US subsidiary is voluntarily recalling two lots of Riomet(metformin hydrochloride oral solution), 500mg/5mL, to the retail level (Class II Recall).

This product, which is indicated to treat type 2 diabetes mellitus in adult and children age 10 and above, is manufactured for Sun by a contract manufacturer. The Riomet lots have 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 could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections. To date, Sun has not received any reports of adverse events related to this recall.

According to a Sun press release, on April 18, 2017, the company notified its wholesale customers through its third-party Recall Coordinator (Inmar Inc) via FedEx standard overnight shipping and has arranged for the return via prepaid FedEx Ground shipping of all recalled products. Consumers that have Riomet which has been recalled should stop using and return it to place of purchase, discard and/or contact their doctor.