Agila Recalls Etomidate Injection Vials

Mylan announced that its subsidiary Agila Specialties is conducting a nationwide recall of 10 lots of Etomidate Injection 2mg/mL.

This recall was initiated due to the potential for small black particles to be present in individual vials. In addition, there was a potential for missing lot number and/or expiry date on the outer carton, as well as a potential for illegible/missing lot number and expiry on individual vials. Administration of these particles, identified as paper shipper labels, may lead to microcirculation impairment, phlebitis, infection, embolism, and infarction.

Etomidate, marketed as Amidate (Hospira), is an intravenous hypnotic agent indicated for the induction of general anesthesia and the supplementation of subpotent anesthetic agents (eg, nitrous oxide in oxygen) during maintenance of anesthesia for short operative procedures (eg, dilation and curettage, cervical conization).

Etomidate 2mg/mL is supplied in 10mL and 20mL glass vials with a Pfizer label. The list of recalled vials are listed below:

NDC

Size

Lot #

Expiration

0069-0006-03

20  mL

5001012

Sep-14



5000927

Jun-14



5000931

Jun-14



5000936

Jun-14



5000942

Jun-14



5001071

Oct-14



5001040

Sep-14

0069-0006-01

10 mL

5001023

Sep-14



5000983

Aug-14



5000986

Aug-14


For more information call (800) 848-0462 or visit Mylan.com.

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