Kalbitor recall: Particulate Matter
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Why was Kalbitor recalled?
Presence of Particulate Matter: Glass
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: A1500009, Exp. Jan 31, 2019
- Product
- Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
- Recalling firm
- Shire
- Quantity
- 3, 536 cartons (3 vials per carton)
- Distribution
- Nationwide and Kuwait
- Recall date
- April 12, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)