{
  "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": "Bengaluru",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209101"
        ],
        "brand_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "generic_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "manufacturer_name": [
          "BluePoint Laboratories"
        ],
        "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": "96569",
      "recalling_firm": "Somerset Therapeutics Private Limited",
      "address_1": "54/1 Budihal Village",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0357-2025",
      "product_description": "Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories  NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)",
      "product_quantity": "23,960 vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Media fill with bacterial contamination",
      "recall_initiation_date": "20250321",
      "center_classification_date": "20250408",
      "report_date": "20250416",
      "code_info": "NDC 68001-581-41; A240482A, exp. date 08/2026;  NDC 68001-581-48; A240482B, exp. date 08/2026"
    }
  ]
}