Class II · Moderate riskOngoing Initiated Feb 27, 2025 (2 years ago)
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
What 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).
Recalling firm
Amgen, Inc.
NDC code
55513-546-01
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0286-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment…