FDA recall D-0625-2017
Shire · Class II · drug
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
Distribution
Nationwide and Kuwait
Key facts
- Status
- Terminated
- Initiation date
- 2017-03-17
- Report date
- 2017-04-12
- Termination date
- 2021-05-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lexington, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0625-2017