FDA-Drug2016-12-28Class II
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
Hazard
Lack of Assurance of Sterility: Potential cracks in glass vials
Sold states
United States and Puerto Rico No foreign distribution.
Affected count
11,434 vials
Manufactured in
1 Amgen Center Dr, N/A, Thousand Oaks, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2017More Amgen, Inc. recalls
- FDA-Drug2026-07-01Amgen Corlanor (ivabradine) 7.5mg tablets recalled for foreign substance
- FDA-Drug2026-07-01Amgen Corlanor (ivabradine) 5 mg tablets recalled for foreign substance contamination
- FDA-Drug2026-07-01Amgen Sensipar 60mg tablets recalled for manufacturing quality deviations
- FDA-Drug2026-07-01Amgen Sensipar (cinacalcet) 90mg tablets recalled for manufacturing compliance issues
- FDA-Drug2026-07-01Amgen Sensipar (cinacalcet) 30mg tablets recalled for manufacturing quality deviations
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