{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Thousand Oaks",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA103353"
        ],
        "brand_name": [
          "NEUPOGEN"
        ],
        "generic_name": [
          "FILGRASTIM"
        ],
        "manufacturer_name": [
          "Amgen, Inc"
        ],
        "product_ndc": [
          "55513-209",
          "55513-530",
          "55513-546",
          "55513-924"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "FILGRASTIM"
        ],
        "rxcui": [
          "727535",
          "727537",
          "727544",
          "727545",
          "1649944",
          "1649946",
          "1649963",
          "1649964"
        ],
        "spl_id": [
          "7f2e6438-4e9a-4619-9e12-a7524d02ee6e"
        ],
        "spl_set_id": [
          "97cc73cc-b5b7-458a-a933-77b00523e193"
        ],
        "package_ndc": [
          "55513-530-01",
          "55513-530-10",
          "55513-530-20",
          "55513-546-01",
          "55513-546-10",
          "55513-546-20",
          "55513-924-01",
          "55513-924-10",
          "55513-924-91",
          "55513-924-20",
          "55513-209-01",
          "55513-209-10",
          "55513-209-91",
          "55513-209-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355513530101",
          "0355513546102"
        ],
        "nui": [
          "M0024696",
          "N0000009451",
          "N0000175666"
        ],
        "pharm_class_cs": [
          "Granulocyte Colony-Stimulating Factor [CS]"
        ],
        "pharm_class_pe": [
          "Increased Myeloid Cell Production [PE]"
        ],
        "pharm_class_epc": [
          "Leukocyte Growth Factor [EPC]"
        ],
        "unii": [
          "PVI5M0M1GW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96325",
      "recalling_firm": "Amgen, Inc.",
      "address_1": "1 Amgen Center Dr",
      "address_2": "N/A",
      "postal_code": "91320-1730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "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.",
      "recall_number": "D-0285-2025",
      "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_date": "20250227",
      "center_classification_date": "20250318",
      "report_date": "20250326",
      "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."
    }
  ]
}