Kalbitor Injection, Solution
FDA Recall NDC 47783-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Kalbitor (NDC 47783-101). A significant event, classified as Class II, was initiated on Mar 17, 2017 by Takeda Pharmaceuticals America, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Glass"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: Glass
Mar 17, 2017
Apr 12, 2017
3, 536 cartons (3 vials per carton)
Recall Profile & Regulatory Data
Event ID
76761
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Shire
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Kuwait
Termination Date
May 25, 2021
Product Description
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Batch or Lot Expiration Information
Lot# : A1500009, Exp. Jan 31, 2019
Affected Packages Involved in this Recall
47783-101-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
