Agila Specialties initiates voluntary nationwide recall of 10 lots of etomidate injection

The 10 lots were manufactured by Agila Specialties Polska in Warsaw, Poland. All of the products bear a Pfizer label. Agila Specialties initiated the recall on 13 February 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 2mg/mL is packaged in glass vials in 10mL and 20mL volumes. Product was distributed Nationwide to distributors, retailers, hospitals, pharmacies, and/or clinics.

Mylan notified its customers of the recall by letter on 13 February 2014. Distributors, retailers, hospitals, pharmacies, or clinics that have product which is being recalled should stop use and discontinue distribution.