Recalls / Class II
Class IID-0285-2025
Product
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).
- Brand name
- Neupogen
- Generic name
- Filgrastim
- Active ingredient
- Filgrastim
- Route
- Intravenous, Subcutaneous
- NDCs
- 55513-209, 55513-530, 55513-546, 55513-924
- FDA application
- BLA103353
- Affected lot / code info
- Lot #: 1147300, 1147300A, Exp.: 2/28/2025; 1152064, Exp.:3/31/2025; 1154734, 1156806, Exp.: 8/31/2025; 1159109, Exp.: 10/31/2025; 1163909, Exp.: 2/28/2026; 1164631, Exp.: 5/31/2026; 1171366, 1182097, Exp.:8/31/2026; 1176114, Exp.: 2/28/2027; 1182094, Exp.:7/31/2027.
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.
Recalling firm
- Firm
- Amgen, Inc.
- Manufacturer
- Amgen, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Amgen Center Dr, N/A, Thousand Oaks, California 91320-1730
Distribution
- Quantity
- 313,620 Vials
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2025-02-27
- FDA classified
- 2025-03-18
- Posted by FDA
- 2025-03-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0285-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.