Alexion Pharmaceuticals, Inc. Recalls

FDA
2
Total Recalls
1
Agencies
Feb 2014
First Recall
Aug 2014
Latest Recall
Sort: Newest first Highest severity

Showing 1-2 of 2 recalls

FDA

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.

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

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.

Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.