Drug recall D-1049-2014
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.
Lots and codes
Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
Recall details
- Recalling firm
- Alexion Pharmaceuticals, Inc., Cheshire, CT
- Quantity
- 21,661 vials
- Distribution
- Nationwide, Puerto Rico, Jamaica, and Grenada.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 4, 2013
- Terminated
- March 2, 2015
Related products
- Soliris – drug information
- NDC 25682-001 Soliris · Eculizumab 300 mg/30mL · Alexion Pharmaceuticals Inc.