Agila Specialties Private Limited, a subsidiary of Mylan Inc., has recalled the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL (see lot breakdown below). 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 Limited 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.
Mylan notified its customers of the recall by letter on Feb. 13. Distributors, retailers, hospitals, pharmacies, or clinics that have product that is being recalled should stop use and discontinue distribution. Consumers with questions regarding this recall can contact Mylan Customer Service with questions at 800-848-0462 on Monday through Friday between 8 a.m. and 5 p.m. EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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