Recalls / Class II
Class IID-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
- Brand name
- Kyprolis
- Generic name
- Carfilzomib
- Active ingredient
- Carfilzomib
- Route
- Intravenous
- NDCs
- 76075-101, 76075-102, 76075-103
- FDA application
- NDA202714
- Affected lot / code info
- Lot #1071559, 1071629; Exp. 05/18
Why it was recalled
Lack of Assurance of Sterility: Potential cracks in glass vials
Recalling firm
- Firm
- Amgen, Inc.
- Manufacturer
- Onyx Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Amgen Center Dr, N/A, Thousand Oaks, California 91320-1730
Distribution
- Quantity
- 11,434 vials
- Distribution pattern
- United States and Puerto Rico No foreign distribution.
Timeline
- Recall initiated
- 2016-12-15
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2017-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0226-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.