{
  "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,
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    }
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  "results": [
    {
      "status": "Ongoing",
      "city": "Bengaluru",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209101"
        ],
        "brand_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "generic_name": [
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        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "70069-031",
          "70069-381",
          "70069-382",
          "70069-383",
          "70069-384"
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        "route": [
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        "substance_name": [
          "HALOPERIDOL DECANOATE"
        ],
        "rxcui": [
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          "859871",
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        "package_ndc": [
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          "70069-030-03",
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          "70069-381-01",
          "70069-381-10",
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          "70069-383-01",
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        ],
        "is_original_packager": [
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        "upc": [
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          "0370069383018",
          "0370069031018",
          "0370069030011",
          "0370069384015"
        ],
        "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-0355-2025",
      "product_description": "Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)",
      "product_quantity": "997 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 70069-381-01; A240467A, exp. date 07/2026;  NDC 70069-381-10; A240467C, exp. date 07/2026"
    }
  ]
}