FDA-Drug2014-08-13Class I
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.
Alexion Pharmaceuticals, Inc.
Hazard
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Sold states
Nationwide and Puerto Rico
Affected count
96,506 vials
Manufactured in
352 Knotter Dr, N/A, Cheshire, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1512-2014Don't want to check this manually?
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