Alexion Pharmaceuticals, Inc. is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion, due to the presence of visible particles detected in a single lot during periodic stability testing. This lot was only distributed in the U.S., and, to date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots.
The lots were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. The company believes it has identified the process component that resulted in the presence of the particles and implemented a change to the process. Alexion does not anticipate any interruption to patient supply.
Following the recall, there will no longer be Soliris in the U.S. manufactured using the previously identified process component that Alexion believes resulted in the stability failure.
The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in the form of an immune reaction and blood clots, which could be life-threatening.
Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening disorders.