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 Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).
Reported: March 26, 2025 Initiated: February 27, 2025 #D-0286-2025
Product Description
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 Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).
Reason for Recall
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Details
- Recalling Firm
- Amgen, Inc.
- Units Affected
- 258,750 Vials
- 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.
- Location
- Thousand Oaks, CA
Frequently Asked Questions
What product was recalled? ▼
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 Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).. Recalled by Amgen, Inc.. Units affected: 258,750 Vials.
Why was this product recalled? ▼
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 26, 2025. Severity: Moderate. Recall number: D-0286-2025.
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