IGMPI India

Alexion Pharmaceuticals, Inc., a biopharmaceutical company has issued a voluntary nationwide 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. The recall is at hospital and user level.

The company has identified the process component that resulted in the presence of the visible particles and implemented a change to the process. The company has not anticipated any interruption to patient supply. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris.

Soliris (eculizumab) is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris is approved in the US (2007), European Union (2007), Japan (2010) and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells). Soliris is indicated to reduce hemolysis in PNH patients. The single affected lot of Soliris is #10007A. Even though, the company is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A. The administration of particulate in parenteral drug can cause potential safety risk to patients in two general areas: immune reaction and blood clots. The particulate matter could also cause blockage of flow of blood in vessels, which can lead to death of the patient.