Mylan's Agila Recalls Injectables Due to Paper Labels in Vials
Mylan Inc. has announced that its subsidiary Agila Specialties, located in Warsaw, Poland, is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection, all of which bear a Pfizer label.
Agila Specialties Private Limited initiated the recall on Feb. 13, 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. Etomidate is a hypnotic drug indicated by intravenous injection for the induction of general anesthesia.
In Dec 2013, Mylan purchased Agila Specialties and its nine facilities in India, Brazil and Poland from India's Strides Arcolab for $1.75B - a deal that was restructured at the last minute due to regulatory infractions at one of Agila's Indian facilities.