Drug 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.
D-1512-2014
Product summary
- Event
- Event 68401
- Status
- Terminated
- Classification
- Class I
- Quantity
- 96,506 vials
- Official record key
drug-enforcement:D-1512-2014
Official wording
Reason: Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Code information: 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
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter