Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Reported: April 12, 2017 Initiated: March 17, 2017 #D-0625-2017
Product Description
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Reason for Recall
Presence of Particulate Matter: Glass
Details
- Recalling Firm
- Shire
- Units Affected
- 3, 536 cartons (3 vials per carton)
- Distribution
- Nationwide and Kuwait
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01. Recalled by Shire. Units affected: 3, 536 cartons (3 vials per carton).
Why was this product recalled? ▼
Presence of Particulate Matter: Glass
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2017. Severity: Moderate. Recall number: D-0625-2017.
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