{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209101"
        ],
        "brand_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "generic_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "68001-578",
          "68001-579",
          "68001-580",
          "68001-581",
          "68001-582"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "rxcui": [
          "859871",
          "1719803",
          "1719862"
        ],
        "spl_id": [
          "048557ea-f859-f0f2-e063-6294a90af5ab"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "68001-579-59",
          "68001-579-48",
          "68001-580-41",
          "68001-581-41",
          "68001-581-48",
          "68001-581-82",
          "68001-578-59",
          "68001-578-48",
          "68001-582-41"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368001578592",
          "0368001581417",
          "0368001579599",
          "0368001582414"
        ],
        "unii": [
          "AC20PJ4101"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96636",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0368-2025",
      "product_description": "Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial,  Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.",
      "product_quantity": "14,189 vials",
      "reason_for_recall": "Lack of assurance of sterility. Bacterial contamination detected in some media fill units",
      "recall_initiation_date": "20250402",
      "center_classification_date": "20250418",
      "report_date": "20250430",
      "code_info": "A240482A, EXP 08/31/2026"
    }
  ]
}