Why it was recalled
Lack of Assurance of Sterility: Potential cracks in glass vials
Product description
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
Lot numbers, UPCs & expiration codes
Lot #1071559, 1071629; Exp. 05/18
Where it was sold
United States and Puerto Rico No foreign distribution.
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-0226-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 15, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 11,434 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amgen, Inc.
Original FDA data
Every field from FDA enforcement report D-0226-2017, exactly as published.
Show all FDA fields
- City
- Thousand Oaks
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 76012
- Address
- 1 Amgen Center Dr
- Code information
- Lot #1071559, 1071629; Exp. 05/18
- Postal code
- 91320-1730
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0226-2017
- Classification
- Class II
- Recalling firm
- Amgen, Inc.
- Product quantity
- 11,434 vials
- Termination date
- Jun 2, 2017
- Reason for recall
- Lack of Assurance of Sterility: Potential cracks in glass vials
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
- Distribution pattern
- United States and Puerto Rico No foreign distribution.
- Recall initiation date
- Dec 15, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2016