Possible Microbial Contamination Prompts Voluntary Recall of Diabetes Drug
This could potentially lead to pneumonia, sinusitis and disseminated infections.
The Food and Drug Administration (FDA) has posted a recall notification for two lots of Riomet (metformin HCl oral solution; Sun Pharmaceuticals) 500mg/5mL due to the possibility that the liquid may be contaminated with Scopulariopsis brevicaulis. Specifically, the affected Riomet includes product with NDC # 10631-206-01 Lot A160031A, Exp: 01/2018, and NDC # 10631-206-02 Lot: A160031B, Exp: 01/2018.
Use of contaminated product could result in infection, especially for immunocompromised patients. The recall notice states that the most plausible portal of entry of Scopulariopsis brevicaulis, a multi-resistant fungal pathogen, is the respiratory tract. This could potentially lead to pneumonia, sinusitis and disseminated infections.
At this time, the Company has not received reports of adverse events related to this recall. Clinicians are urged to report adverse reactions related to the use of this product to the FDA's MedWatch program.
Riomet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children (≥10 years old) with type 2 diabetes mellitus. It is supplied in 118mL and 473mL bottles.
Sun pharmaceutical industries inc. issues voluntary nationwide recall of Riomet® (metformin hydrochloride oral solution) manufactured by a contract manufacturer due to microbial contamination [press release]. Silver Springs, Maryland: US Food and Drug Administration. Published November 24, 2017. Accessed November 30, 2017.