Status
Ongoing
Drug Enforcement D-0286-2025
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
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Product Information
- 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).
- Product quantity
- 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.
- 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-0286-2025
- Event ID
- 96325
- Recall initiation date
- February 27, 2025
- Center classification date
- March 18, 2025
- 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.
- More code info
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