Home / Recalls / Alexion Pharmaceuticals, Inc. / D-1512-2014

D-1512-2014 Class I Terminated

Recalled by Alexion Pharmaceuticals, Inc. — Cheshire, CT

Recall Details

Product Type: Drugs
Report Date: August 13, 2014
Initiation Date: June 2, 2014
Termination Date: May 29, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 96,506 vials

Product Description

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15