Drug product
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
D-0625-2017
Product summary
- Firm
- Shire
- Event
- Event 76761
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3, 536 cartons (3 vials per carton)
- Official record key
drug-enforcement:D-0625-2017
Official wording
Reason: Presence of Particulate Matter: Glass
Code information: Lot #: A1500009, Exp. Jan 31, 2019
Distribution pattern: Nationwide and Kuwait
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter