Credit: Globovision
The manufacturer of the recently approved eculizumab (Soliris) issued a voluntary US recall on June 2 of a single affected lot of the drug, although it included 8 additional lots in the recall.
The manufacturer, Alexion Pharmaceuticals, found visible particulates in the 300 mg/30 mL concentrated solution for intravenous infusion, which could cause an immune reaction and blood clots in patients receiving the drug.
The single affected Soliris lot, distributed in the US only, is #1007A. Also included in the U.S. recall are lots 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A, and 10008A.
All lots in the recall were manufactured using the same process component.
Alexion believes it has identified the part of the process that has resulted in the visible particles in the solution and has changed the process component.
An earlier recall of eculizumab, also for particulate matter, occurred in December 2013.
Alexion does not anticipate any interruption to the patient supply of eculizumab.
Eculizumab recently received full US Food and Drug Administration (FDA) approval to treat adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS). It had received accelerated approval for this indication in 2011.
Eculizumab is also FDA-approved to treat patients with paroxysmal nocturnal hemoglobinuria.
For more information on the recall, visit the company website.
Healthcare professionals and patients should report adverse events or side effects related to Soliris to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
