Alexion Pharmaceuticals, Inc. recalls Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals,

Recalled August 13, 2014 · FDA recall D-1512-2014 · Alexion Pharmaceuticals

Hazard

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

Units

96,506 vials

Sold at

Nationwide and Puerto Rico

Description

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

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.

Manufacturer(s)

Alexion Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →