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.

Recall Number: D-1512-2014

Firm: Alexion Pharmaceuticals, Inc.

Classification: Class I

Status: Terminated

Report Date: 20140813

Initiation Date: 20140602

Termination Date: 20150529

Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.

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.