Product: Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
Reason for recall: Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Recall initiated: 20140602
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated