FDA Recall D-1512-2014

Alexion Pharmaceuticals, Inc. · Cheshire, CT

Class I — life-threatening Terminated 361 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: 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

Quantity: 96,506 vials

Reason for recall

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

Recall record

Recall number: D-1512-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide and Puerto Rico
Recall initiated: 2014-06-02
Classified by FDA Center: 2014-08-05
FDA published: 2014-08-13
Terminated: 2015-05-29
Recalling firm: Alexion Pharmaceuticals, Inc.
Firm location: Cheshire, CT

Drug identification

Brand name(s): SOLIRIS
Generic name(s): ECULIZUMAB
Manufacturer(s): Alexion Pharmaceuticals Inc.
NDC(s): 25682-001
Route(s): INTRAVENOUS

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