Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. As previously stated, Alexion believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process.
Two lots were found to contain visible particles. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
December 13, 2013 - Cheshire, Conn., – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today is providing further information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles.