{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209101"
        ],
        "brand_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "generic_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "manufacturer_name": [
          "Somerset Therapeutics, LLC"
        ],
        "product_ndc": [
          "70069-030",
          "70069-031",
          "70069-381",
          "70069-382",
          "70069-383",
          "70069-384"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "rxcui": [
          "859867",
          "859871",
          "1719803",
          "1719862"
        ],
        "spl_id": [
          "f6d888a0-65a7-4073-8671-b00b4bfaff4c"
        ],
        "spl_set_id": [
          "f2bff27f-929f-4f7d-b3eb-084ebc2a885f"
        ],
        "package_ndc": [
          "70069-030-05",
          "70069-030-03",
          "70069-031-01",
          "70069-031-05",
          "70069-381-01",
          "70069-381-10",
          "70069-382-01",
          "70069-382-05",
          "70069-383-05",
          "70069-383-10",
          "70069-383-01",
          "70069-384-01",
          "70069-384-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370069382011",
          "0370069383018",
          "0370069031018",
          "0370069030011",
          "0370069384015"
        ],
        "unii": [
          "AC20PJ4101"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94452",
      "recalling_firm": "SOMERSET THERAPEUTICS LLC",
      "address_1": "300 Franklin Square Dr",
      "address_2": "",
      "postal_code": "08873-4187",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0506-2024",
      "product_description": "Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.",
      "product_quantity": "5,578 units",
      "reason_for_recall": "Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).",
      "recall_initiation_date": "20240424",
      "center_classification_date": "20240521",
      "report_date": "20240529",
      "code_info": "Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025",
      "more_code_info": ""
    }
  ]
}