drugs Class I Updated 2014-08-13

Alexion Pharmaceuticals, Inc. recalls Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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