CLASS II Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Kalbitor (ecallantide), 10mg/mL recalled by Shire
Shire is recalling Kalbitor (ecallantide), 10mg/mL, distributed nationwide in the US. The recall was initiated on 17 Mar 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0625-2017
- FDA event ID
- 76761
- Recalling firm
- Shire, Lexington, MA
- Brand
- Kalbitor
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2017
- FDA classified
- 31 Mar 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Mar 2017 | Recall initiated by company | |
| 31 Mar 2017 | Classified by FDA | +14 days |
| 12 Apr 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Glass
Product as listed by the FDA
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Where it was distributed
Nationwide and Kuwait
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Glass
Which lots are affected?
Lot #: A1500009, Exp. Jan 31, 2019
Where was it sold?
Nationwide and Kuwait
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS III | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalledPentasa | Shire | Other | Nationwide |
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