{
  "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"
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        "spl_id": [
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        ],
        "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-0422-2015",
      "product_description": "Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103",
      "product_quantity": "2,523 cartons (25,936 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 7602368, Exp 7/16; Lot 7602369, Exp 7/16",
      "more_code_info": ""
    }
  ]
}