Mylan Inc., located in Pennsylvania, is the third largest generic and specialty pharmaceuticals company in the world. Mylan is issuing a recall of ten lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL. Etomidate is an injectable hypnotic drug used in anesthesia. The drug is being voluntarily recalled due to the potential presence of paper shipper labels, visible as small black particles, in the vials. There may be missing lot numbers and/or expiration dates on the outer carton and the potential for illegible or missing lot numbers and expiration dates on individual vials. According to the press release, “Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction. Mylan and Pfizer have not received any reports of adverse events related to the recalled product to date.” (PR Newswire, 2/14/14)
The recalled lots were manufactured by Mylan’s subsidiary, Agila Specialties Private Limited, through its division located in Warsaw, Poland. The products being recalled carry the Pfizer label.
Etomidate is injected intravenously for the induction of general anesthesia. The product was distributed throughout the United States to distributors, retailers, hospitals, pharmacies, and/or clinics. It is not clear how many vials are in each lot or the total number of injection vials being recalled at this time. The recall is a “voluntary” one, initiated on February 13, 2014, with the knowledge of the Food and Drug Administration. To date there have been no reports of adverse events.