Mylan announced that its subsidiary Agila Specialties Private Limited has initiated a voluntary nationwide recall of its hypnotic drug Etomidate injection. The company cited the presence of particulate matter and/or illegible and missing lot number and/or expiry date on the products’ label as the reason.
Etomidate is a hypnotic drug without analgesic activity intended for the induction of general anesthesia. The drug is also indicated as a supplement of subpotent anesthetic agents. Etomidate 2 mg/mL is packaged and distributed in glass vials in 10 mL and 20 mL volumes.
Agila identified 10 lots of Etomidate injection 2 mg/mL - 10 mL and 20 mL for the recall 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.” The lots were manufactured by Agila Specialties Polska sp.zo.o in Warsaw, Poland and bear a Pfizer label.
The list of affected Etomidate lots includes the following:
Etomidate Injection 2 mg/mL
NDC Size Lot # Expiration
0069-0006-03 20 mL 5001012 Sep-14
0069-0006-01 10 mL 5001023 Sep-14
The company said it is conducting the recall with the knowledge of the U.S. Food and Drug Administration (FDA). Pfizer together with Mylan said no adverse events related to the recall had been reported to date. The affected lots were distributed nationwide to distributors, hospitals, pharmacies, retailers, and/or clinics. Patients or healthcare providers are encouraged to report any adverse experiences or problems that may be related to the affected Etomidate lots to Mylan. Adverse events may also be reported to the FDA MedWatch Adverse Event Reporting program.