Agila Specialties Private Ltd., a subsidiary of Mylan Inc., is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL - 10 mL and 20 mL. The 10 lots were manufactured by Agila Specialties Polska sp.zo.o in Warsaw, Poland. All of the products bear a Pfizer label.
Agila Specialties Private Ltd. initiated the recall on Feb. 13, 2014, due to the potential for small black particles, identified as paper shipper labels, to be present in individual vials; the potential for missing lot number and/or expiry date on the outer carton, and the potential for illegible/missing lot number and expiry on individual vials. 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.
Etomidate is a hypnotic drug without analgesic activity. It is indicated by intravenous injection for the induction of general anesthesia. Etomidate is also indicated for the supplementation of subpotent anesthetic agents. Etomidate 2 mg/mL is packaged in glass vials in 10 mL and 20 mL volumes. Product was distributed Nationwide to distributors, retailers, hospitals, pharmacies, and/or clinics.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.