Amgen, Inc.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 2
- Inspections
- 28
- Compliance Actions
- 1
Known Names
amgen, amgen-manufacturing-limited, amgen-singapore-manufacturing-pte, amgen-technology-ireland-unlimited, amgen singapore manufacturing pte, amgen technology ireland unlimited, amgen manufacturing limited, amgen europe, amgen-europe, amgen singapore manufacturing
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0286-2025 | Class II | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only | February 27, 2025 |
| D-0285-2025 | Class II | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous | February 27, 2025 |
| D-0855-2022 | Class II | MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single do | May 2, 2022 |
| D-1173-2017 | Class II | Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-31 | September 13, 2017 |
| D-1086-2017 | Class II | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx o | August 4, 2017 |
| D-0226-2017 | Class II | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous | December 15, 2016 |
| D-66318-001 | Class II | Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, | September 17, 2013 |