Drug product
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
D-0226-2017
Product summary
- Firm
- Amgen, Inc.
- Event
- Event 76012
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,434 vials
- Official record key
drug-enforcement:D-0226-2017
Official wording
Reason: Lack of Assurance of Sterility: Potential cracks in glass vials
Code information: Lot #1071559, 1071629; Exp. 05/18
Distribution pattern: United States and Puerto Rico No foreign distribution.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility