Sun Pharmaceuticals Industries is recalling two lots of the type 2 diabetes medication Riomet oral solution, manufactured by SPII, because the solution is contaminated with a fungal pathogen called Scopulariopsis brevicaulis, which could cause infections especially in people with weakened immune systems. Infections would most likely in the respiratory tract, which could lead to pneumonia or sinusitis, or possibly disseminated infections. To date, SPII has not received any reports of adverse events related to this recall.
The contaminant was discovered during sample preparation for the Antimicrobial Preservative Effectiveness testing performed as part of the 12-month stability study interval.
The recall affects two lots of Riomet (metformin hydrochloride oral solution), which is used to treat type 2 diabetes in adults and children age 10 and older. The product is packaged in 118 mL (4 fl. oz.) and 473 mL (16 fl. oz.) bottles marked with the NDC Code 10631-206-01 Lot A160031A, with the expiration date 01/2018; or NDC 10631-206-02 Lot A160031B, with the expiration date 01/2018. The oral solution was distributed nationwide to wholesale customers.
SPII has notified its wholesale customers and arranged for the return of the product. Anyone with affected Riomet oral solution should stop using it and return it to the place of purchase, discard and/or contact their doctor.
Any adverse events related to affected Riomet should file a report with the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice