Drug 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.
D-1049-2014
Product summary
- Event
- Event 66771
- Status
- Terminated
- Classification
- Class I
- Quantity
- 21,661 vials
- Official record key
drug-enforcement:D-1049-2014
Official wording
Reason: Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Code information: Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
Distribution pattern: Nationwide, Puerto Rico, Jamaica, and Grenada.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter