Alexion is providing instructions to individuals at the hospital/user level regarding a recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. The two lots were found to contain visible particles.
Infusion of particulate matter found in a parenteral drug can lead to potential immunogenicity and the occurrence of thromboembolic events. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
The affected product is Soliris 300mg/30mL Concentrated solution for intravenous infusion NDC 25682-001-01 with lot # 10010A and 10001-1. Alexion is notifying customers to not use the product from the recalled lot and to return the product.
Soliris is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare disorders.
For more information call (888) SOLIRIS or visit FDA.gov.