D-0625-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2017
- Initiation Date
- March 17, 2017
- Termination Date
- May 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3, 536 cartons (3 vials per carton)
Product Description
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
Distribution Pattern
Nationwide and Kuwait
Code Information
Lot #: A1500009, Exp. Jan 31, 2019