Drug recall D-0226-2017
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
Reason for recall
Lack of Assurance of Sterility: Potential cracks in glass vials
Lots and codes
Lot #1071559, 1071629; Exp. 05/18
Recall details
- Recalling firm
- Amgen, Inc., Thousand Oaks, CA
- Quantity
- 11,434 vials
- Distribution
- United States and Puerto Rico No foreign distribution.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 15, 2016
- Terminated
- June 2, 2017
Related products
- Kyprolis – drug information
- NDC 76075-103 Kyprolis · Carfilzomib 10 mg/5mL · Onyx Pharmaceuticals, Inc.
- NDC 76075-102 Kyprolis · Carfilzomib 30 mg/15mL · Onyx Pharmaceuticals, Inc.
- NDC 76075-101 Kyprolis · Carfilzomib 60 mg/30mL · Onyx Pharmaceuticals, Inc.