Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous o
Summary
The FDA issued a Class II for Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL singl by Amgen, Inc.. 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..
Details
Source
Drug Recall
External ID
D-0286-2025
Action Date
2025-03-26
Status
Ongoing
Category
drug
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).
Lot/Code Info: Lot 1147308, 1154183, Exp.: 2/28/2025; 1156807, 1160222, Exp.: 6/30/2025; 1160223, 1163912, 1167352, Exp.: 2/28/2026; 1171365, 1175057, 1176250, Exp.: 11/30/2026.
Quantity Affected: 258,750 Vials
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-27
Company
Thousand Oaks, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amgen, Inc. has 9 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amgen, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amgen, Inc. have FDA actions?
Amgen, Inc. has 9 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0286-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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