Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial recall — FDA D-1512-2014
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Overview of recall records associated with Alexion Pharmaceuticals, Inc., including dates, categories and classifications where available.
Classification mix: Class I: 2.
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
This page summarizes recall records in which the official source identifies Alexion Pharmaceuticals, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.