FILGRASTIM Recall D-0285-2025
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).
FILGRASTIM Recall D-0285-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0285-2025 |
| Event ID | 96325 |
| Brand | NEUPOGEN |
| Generic Name | FILGRASTIM |
| Manufacturer | FILGRASTIM |
| Original Package? | 1 |
| Active Substance | FILGRASTIM |
| Drug Route | INTRAVENOUS |
| 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. |
| Quantity | 313,620 Vials |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20250326 |
| Product NDC | 55513-209 55513-530 55513-546 |
| Product NUI | M0024696 N0000009451 N0000175666 |
| Drug UPC | 0355513530101 0355513546102 |
| Pharma Class (PE) | Increased Myeloid Cell Production [PE] |
| Pharma Class (EPC) | Leukocyte Growth Factor [EPC] |
| Pharma Class (CS) | Granulocyte Colony-Stimulating Factor [CS] |
| Recall Initiation Date | 20250227 |
| Report Date | 20250326 |
| Classification Date | 20250318 |
| Address | 1 Amgen Center DrN/A Thousand Oaks, CA 91320-1730 United States |
| Recalling Firm | Amgen, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | PVI5M0M1GW |
| Drug Application Number | BLA103353 |
| Structured Product Labeling (SPL ID) | fac82162-7085-4ed4-b04b-44ffe5384518 |
| Structured Product Labeling (SPL Set ID) | 97cc73cc-b5b7-458a-a933-77b00523e193 |
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