Agila Specialties Private Limited, a subsidiary of Mylan Inc, has initiated a voluntary nationwide recall to the hospital/user level of 10 lots of etomidate injection 2 mg/mL because of multiple potential problems.
Etomidate is a short-acting intravenous anesthetic agent packaged in glass vials in 10- and 20-mL volumes.
The recalled lots of etomidate were manufactured in Warsaw, Poland; bear a Pfizer label; and were sent to distributors, retailers, hospitals, pharmacies, and/or clinics in the United States.
With the recalled lots, there is 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,” Mylan said in a statement posted on the US Food Drug Administration (FDA)Web site.
“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,” Mylan said.