Why it was recalled
Presence of Particulate Matter: Glass
Product description
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Lot numbers, UPCs & expiration codes
Lot #: A1500009, Exp. Jan 31, 2019
Where it was sold
Nationwide and Kuwait
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0625-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 17, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 3, 536 cartons (3 vials per carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shire
Original FDA data
Every field from FDA enforcement report D-0625-2017, exactly as published.
Show all FDA fields
- City
- Lexington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 76761
- Address
- 300-400 Shire Way
- Code information
- Lot #: A1500009, Exp. Jan 31, 2019
- Postal code
- 02421-2101
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0625-2017
- Classification
- Class II
- Recalling firm
- Shire
- Product quantity
- 3, 536 cartons (3 vials per carton)
- Termination date
- May 25, 2021
- Reason for recall
- Presence of Particulate Matter: Glass
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
- Distribution pattern
- Nationwide and Kuwait
- Recall initiation date
- Mar 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 31, 2017