Recalls / Class I
Class ID-1512-2014
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), 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
- Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15
Why it was recalled
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Recalling firm
- Firm
- Alexion Pharmaceuticals, Inc.
- Manufacturer
- Alexion Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 352 Knotter Dr, N/A, Cheshire, Connecticut 06410-1138
Distribution
- Quantity
- 96,506 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-06-02
- FDA classified
- 2014-08-05
- Posted by FDA
- 2014-08-13
- Terminated
- 2015-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1512-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.