Recalls / Class I
Class ID-1049-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Soliris
- Generic name
- Eculizumab
- Active ingredient
- Eculizumab
- Route
- Intravenous
- NDC
- 25682-001
- FDA application
- BLA125166
- Affected lot / code info
- Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
Why it was recalled
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Recalling firm
- Firm
- Alexion Pharmaceuticals, Inc.
- Manufacturer
- Alexion Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 352 Knotter Dr, Cheshire, Connecticut 06410-1138
Distribution
- Quantity
- 21,661 vials
- Distribution pattern
- Nationwide, Puerto Rico, Jamaica, and Grenada.
Timeline
- Recall initiated
- 2013-11-04
- FDA classified
- 2014-01-30
- Posted by FDA
- 2014-02-05
- Terminated
- 2015-03-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1049-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.