Key Takeaway
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, ND by Amgen, Inc. was recalled on February 27, 2025. The hazard: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, ND
Description
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).
Hazard / Reason
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, ND
DrugsCompany Information
Amgen, Inc.
Thousand Oaks, CA, United States
View all 7 recalls by Amgen, Inc. →Distribution
Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.
Related Recalls
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand
February 27, 2025
MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01
May 2, 2022
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc.
September 13, 2017
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products,
August 4, 2017
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
December 15, 2016
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799
September 17, 2013
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.