Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
What was recalled
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.
- Recalling firm
- Alexion Pharmaceuticals, Inc.
- NDC code
- 25682-001-01
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1049-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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