Status
Ongoing
Drug Enforcement D-0285-2025
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Classification
Class II
Report Date
March 26, 2025
Termination Date
—
Product Information
- Product 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).
- Product quantity
- 313,620 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- 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.
Location & Firm
- Recalling firm
- Amgen, Inc.
- Address
-
1 Amgen Center Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0285-2025
- Event ID
- 96325
- Recall initiation date
- February 27, 2025
- Center classification date
- March 18, 2025
- 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.
- More code info
- —