{
  "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": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA072494"
        ],
        "brand_name": [
          "FLUOCINONIDE"
        ],
        "generic_name": [
          "FLUOCINONIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-1254",
          "51672-1253",
          "51672-1279",
          "51672-1264"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FLUOCINONIDE"
        ],
        "rxcui": [
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          "103457",
          "310362",
          "1801283"
        ],
        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "51672-1253-2",
          "51672-1253-3",
          "51672-1253-4",
          "51672-1254-1",
          "51672-1254-2",
          "51672-1254-3",
          "51672-1279-1",
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          "51672-1279-3",
          "51672-1264-1",
          "51672-1264-2",
          "51672-1264-3"
        ],
        "is_original_packager": [
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        "upc": [
          "0351672126414",
          "0351672127923"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "2W4A77YPAN"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78157",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "N/A",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0146-2018",
      "product_description": "Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada  L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1",
      "product_quantity": "16,944 tubes",
      "reason_for_recall": "Cross contamination with other products: traces of Dapsone were found in the finished product.",
      "recall_initiation_date": "20170920",
      "center_classification_date": "20171229",
      "termination_date": "20200910",
      "report_date": "20171101",
      "code_info": "Lot #: A771026850, Exp 6/18"
    }
  ]
}