FDA-Drug2014-02-05Class I
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.
Alexion Pharmaceuticals, Inc.
Hazard
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Sold states
Nationwide, Puerto Rico, Jamaica, and Grenada.
Affected count
21,661 vials
Manufactured in
352 Knotter Dr, Cheshire, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2014Don't want to check this manually?
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