NDC 47783-101
Kalbitor 10 mg per 1 mL injection, solution
On the label: Takeda Pharmaceuticals America, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| FUJIFILM Diosynth Biotechnologies UK Ltd | Billingham, United Kingdom | Makes the active ingredient | Problems found, fixed voluntarilyMar 17, 2023 · 6 inspections |
| Jubilant HollisterStier LLC | Spokane, WA, United States | Makes it, packages it and labels it | No problems foundMar 5, 2021 · 13 inspections, 1 with FDA action |
Recalls
- Mar 17, 2017 · Class II · Shire
Presence of Particulate Matter: Glass
Lots: Lot #: A1500009, Exp. Jan 31, 2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ecallantide: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 10 mg per 1 mL
- Approval
- BLA BLA125277
- On the market since
- Feb 2, 2010
- Package NDCs
47783-101-01- Official label
- DailyMed (National Library of Medicine), updated Jul 1, 2025
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