Alexion Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
0
Inspections
23
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-1512-2014Class ISoliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: AlexJune 2, 2014
D-1049-2014Class ISoliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 3November 4, 2013