FDA Recall D-1049-2014
Alexion Pharmaceuticals, Inc. · Cheshire, CT
Class I — life-threatening Terminated 483 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Reason for recall
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Recall record
- Recall number
D-1049-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide, Puerto Rico, Jamaica, and Grenada.
- Recall initiated
- 2013-11-04
- Classified by FDA Center
- 2014-01-30
- FDA published
- 2014-02-05
- Terminated
- 2015-03-02
- Recalling firm
- Alexion Pharmaceuticals, Inc.
- Firm location
- Cheshire, CT
Drug identification
- Brand name(s)
- SOLIRIS
- Generic name(s)
- ECULIZUMAB
- Manufacturer(s)
- Alexion Pharmaceuticals Inc.
- NDC(s)
25682-001- Route(s)
- INTRAVENOUS