Drug recall D-1512-2014
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.
Reason for recall
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Lots and codes
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
Recall details
- Recalling firm
- Alexion Pharmaceuticals, Inc., Cheshire, CT
- Quantity
- 96,506 vials
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 2, 2014
- Terminated
- May 29, 2015
Related products
- Soliris – drug information
- NDC 25682-001 Soliris · Eculizumab 300 mg/30mL · Alexion Pharmaceuticals Inc.