{
  "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": "Rockford",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075440"
        ],
        "brand_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "generic_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "manufacturer_name": [
          "Mylan Institutional LLC"
        ],
        "product_ndc": [
          "67457-409",
          "67457-410",
          "67457-382",
          "67457-381"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "rxcui": [
          "859867",
          "859871",
          "1719803",
          "1719862"
        ],
        "spl_id": [
          "de6fba7e-eade-43a8-aa68-5b84bf3aa086"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "67457-410-00",
          "67457-410-13",
          "67457-382-00",
          "67457-382-58",
          "67457-409-00",
          "67457-409-13",
          "67457-381-00",
          "67457-381-58"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0367457409139",
          "0367457381589",
          "0367457382586"
        ],
        "unii": [
          "AC20PJ4101"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70564",
      "recalling_firm": "Mylan Institutional LLC",
      "address_1": "4901 Hiawatha Dr",
      "address_2": "",
      "postal_code": "61103-1287",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0421-2015",
      "product_description": "Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103",
      "product_quantity": "11,030 cartons (55,150 vials)",
      "reason_for_recall": "Lack of Assurance of Sterility; due to leaking vials",
      "recall_initiation_date": "20150218",
      "center_classification_date": "20150323",
      "termination_date": "20170223",
      "report_date": "20150401",
      "code_info": "Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16",
      "more_code_info": ""
    }
  ]
}