Soliris Vials Found to Contain Visible Particles
Alexion announced a voluntary recall of certain lots of Soliris (eculizumab) 300mg/30mL concentrated solution for IV infusion. This recall is due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing. Soliris is approved for treatment in patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
The recalled products contain Lot #10007A, 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A, and 10008A. The affected lots were manufactured using a process component during vial filling identified in the November 2013 recall. The company has identified the process component that resulted in the presence of the visible particles and has implemented change.
If the particulate is administered through infusion, it may pose potential safety risks such as immune reactions and blood clots. Particulates may block blood flow in vessels, which may be life-threatening.
Alexion is notifying its distributors and customers by letter and is arranging for replacement of all recalled products.
For more information call (888) 765-4747 or visit Soliris.com.