Alexion Pharmaceuticals has announced that it is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion to the hospital/user level. Alexion states that the lots were manufactured using a process component during vial filling identified in the November 2013 recallAlexion has identified the process component that resulted in the presence of the visible particles and implemented a change to the process; the company does not anticipate any interruption to patient supply. The recall was initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the United States and the company states that no safety risks to patients who have received Soliris have been identified.
The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the US recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A, and 10008A. Following this voluntary recall, there will no longer be Soliris in the US manufactured using the previously identified process component that Alexion believes resulted in the stability failure.
The company states that, to date, there have been no product complaints of particulates or identifiable safety concerns attributed to the product consumed from the affected lots. As product from the affected lot was last shipped on October 29, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level.
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.