Alexion Pharmaceuticals recalls
FDA enforcement reports naming Alexion Pharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 2
- Most recent report
- Aug 13, 2014
- Aug 13, 2014Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufact…Drug · Alexion Pharmaceuticals, Inc.Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.Class I
- Feb 5, 2014Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL…Drug · Alexion Pharmaceuticals, Inc.Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.Class I