Drug recall D-0625-2017
Product
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Reason for recall
Presence of Particulate Matter: Glass
Lots and codes
Lot #: A1500009, Exp. Jan 31, 2019
Recall details
- Recalling firm
- Shire, Lexington, MA
- Quantity
- 3, 536 cartons (3 vials per carton)
- Distribution
- Nationwide and Kuwait
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 17, 2017
- Terminated
- May 25, 2021
Related products
- Kalbitor – drug information
- NDC 47783-101 Kalbitor · Ecallantide 10 mg/mL · Takeda Pharmaceuticals America, Inc.