{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA074893"
        ],
        "brand_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "generic_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-469",
          "63323-471"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "rxcui": [
          "859867",
          "859871",
          "1719803",
          "1719862"
        ],
        "spl_id": [
          "86dff2aa-2ab3-42fc-989e-619b13ace573"
        ],
        "spl_set_id": [
          "ca9896e0-fb2e-46a4-8700-20d144c14764"
        ],
        "package_ndc": [
          "63323-469-01",
          "63323-469-05",
          "63323-471-01",
          "63323-471-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "AC20PJ4101"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73652",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0818-2016",
      "product_description": "Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.",
      "product_quantity": "48,210 units",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.",
      "recall_initiation_date": "20160407",
      "center_classification_date": "20160411",
      "termination_date": "20161107",
      "report_date": "20160420",
      "code_info": "Lot #: 6111080, Exp. 01/2017",
      "more_code_info": ""
    }
  ]
}