Alexion Pharmaceuticals, Inc. recalls Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial
Recalled February 5, 2014 · FDA recall D-1049-2014 · Alexion Pharmaceuticals
Hazard
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. · FDA Class I
Units
21,661 vials
Sold at
Nationwide, Puerto Rico, Jamaica, and Grenada.
Description
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
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.
Manufacturer(s)
Alexion Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →