D-1049-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2014
- Initiation Date
- November 4, 2013
- Termination Date
- March 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,661 vials
Product Description
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.
Distribution Pattern
Nationwide, Puerto Rico, Jamaica, and Grenada.
Code Information
Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15