drugs Class I Updated 2014-02-05

Alexion Pharmaceuticals, Inc. recalls Soliris (eculizumab) Concentrated Solution for Intravenous I

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
View official government recall

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