{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Thousand Oaks",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA103234"
        ],
        "brand_name": [
          "PROCRIT"
        ],
        "generic_name": [
          "ERYTHROPOIETIN"
        ],
        "manufacturer_name": [
          "Janssen Products, LP"
        ],
        "product_ndc": [
          "59676-302",
          "59676-303",
          "59676-304",
          "59676-310",
          "59676-340",
          "59676-312",
          "59676-320"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "EPOETIN"
        ],
        "rxcui": [
          "205913",
          "205918",
          "205922",
          "205924",
          "212219",
          "213475",
          "239998",
          "239999",
          "240000",
          "240377",
          "241999",
          "242706",
          "1721684",
          "1721690"
        ],
        "spl_id": [
          "325d5d88-413d-28a2-e063-6394a90a3948"
        ],
        "spl_set_id": [
          "0c721ba4-ae19-417f-aae1-221ed1a0866a"
        ],
        "package_ndc": [
          "59676-303-00",
          "59676-303-01",
          "59676-304-00",
          "59676-304-01",
          "59676-310-00",
          "59676-310-01",
          "59676-310-02",
          "59676-302-00",
          "59676-302-01",
          "59676-340-00",
          "59676-340-01",
          "59676-312-00",
          "59676-312-04",
          "59676-320-00",
          "59676-320-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "64FS3BFH5W"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78110",
      "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": "U.S.A. Nationwide",
      "recall_number": "D-1173-2017",
      "product_description": "Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044",
      "product_quantity": "275,380 vials",
      "reason_for_recall": "Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.",
      "recall_initiation_date": "20170913",
      "center_classification_date": "20170919",
      "termination_date": "20180329",
      "report_date": "20170927",
      "code_info": "Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18",
      "more_code_info": ""
    }
  ]
}