Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 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-1049-2014

Firm: Alexion Pharmaceuticals, Inc.

Classification: Class I

Status: Terminated

Report Date: 20140205

Initiation Date: 20131104

Termination Date: 20150302

Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.

Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 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.