FDA Drug recall D-0625-2017
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
- FDA Drug
- Class II
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class II recall of Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 by Shire, citing presence of Particulate Matter: Glass.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0625-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-17 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Shire |
| Distribution | US |
Product
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Reason
Presence of Particulate Matter: Glass
Identifiers
| ndc | 47783-101-01 |
|---|---|
| code_info | Lot #: A1500009, Exp. Jan 31, 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0625-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.