Drug recall
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA…
FDA recall event 76761 · Class II · Shire
Key facts
| Event ID | 76761 |
|---|---|
| Recall numbers | D-0625-2017 |
| Recalling firm | Shire |
| Product type | Drugs |
| Products | Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Glass |
| Initiation date | Mar 17, 2017 |
| Report date | Apr 12, 2017 |
| Termination date | May 25, 2021 |
| City | Lexington |
| State | MA |
| Country | United States |
| FEI number | 3009340644 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: