Recall Issued Because of Potential Label Particulates, Potential Missing Lot and Expiry Numbers
Labeling issues reportedly have prompted a voluntary recall. According to a statement on FDA's Web site, Mylan subsidiary Agila Specialties Private Limited is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL and 20 mL. Particulate matter consisting of small black particles "identified as paper shipper labels" could be found in individual vials. In addition, outer cartons may be missing lot numbers and/or expiry dates and individual vials may be missing or bearing illegible lot numbers and expiry dates.
Agila Specialties Polska reportedly made the 10 lots in Warsaw, Poland, which carry a Pfizer label. According to the statement, Mylan and Pfizer have not received any reports of adverse events related to the recalled product to date.
For intravenous injection for the induction of general anesthesia, Etomidate 2 mg/mL is packaged in glass vials in 10 mL and 20 mL volumes.
Mylan notified its customers of the recall by letter on Feb.13, 2014. Distributors, retailers, hospitals, pharmacies, or clinics that have product which is being recalled should stop use and discontinue distribution, it was reported.
For more details, read the statement here. Consumers can contact Mylan Customer Service at 800/848-0462.