{
  "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": "Melrose Park",
      "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": "68019",
      "recalling_firm": "Fresenius Kabi USA LLC",
      "address_1": "2020 N Ruby St",
      "address_2": "",
      "postal_code": "60160-1112",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0247-2015",
      "product_description": "HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC  63323-469-01",
      "product_quantity": "216,517 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.",
      "recall_initiation_date": "20140414",
      "center_classification_date": "20141113",
      "termination_date": "20160308",
      "report_date": "20141119",
      "code_info": "Lot  6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15",
      "more_code_info": ""
    }
  ]
}