Recalls / Class II
Class IID-0625-2017
Product
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
- Brand name
- Kalbitor
- Generic name
- Ecallantide
- Active ingredient
- Ecallantide
- Route
- Subcutaneous
- NDC
- 47783-101
- FDA application
- BLA125277
- Affected lot / code info
- Lot #: A1500009, Exp. Jan 31, 2019
Why it was recalled
Presence of Particulate Matter: Glass
Recalling firm
- Firm
- Shire
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300-400 Shire Way, N/A, Lexington, Massachusetts 02421-2101
Distribution
- Quantity
- 3, 536 cartons (3 vials per carton)
- Distribution pattern
- Nationwide and Kuwait
Timeline
- Recall initiated
- 2017-03-17
- FDA classified
- 2017-03-31
- Posted by FDA
- 2017-04-12
- Terminated
- 2021-05-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0625-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.