Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc. appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 25 FDA inspections, and 1 compliance action on record. Its most recent recall (D-1512-2014, Class I) was initiated on June 2, 2014.
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 25
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1512-2014 | Class I | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alex | June 2, 2014 |
| D-1049-2014 | Class I | Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 3 | November 4, 2013 |