{
  "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": [
          "103456",
          "103457",
          "310362",
          "1801283"
        ],
        "spl_id": [
          "46a43966-e83f-a3cc-e063-6394a90af22d"
        ],
        "spl_set_id": [
          "b0bc89a9-c9d5-4adb-9785-2d4487c4c656"
        ],
        "package_ndc": [
          "51672-1253-1",
          "51672-1253-2",
          "51672-1253-3",
          "51672-1253-4",
          "51672-1254-1",
          "51672-1254-2",
          "51672-1254-3",
          "51672-1279-1",
          "51672-1279-2",
          "51672-1279-3",
          "51672-1264-1",
          "51672-1264-2",
          "51672-1264-3"
        ],
        "is_original_packager": [
          true
        ],
        "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": "76837",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0790-2017",
      "product_description": "Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532,  NDC 51672-1254-3",
      "product_quantity": "7,776 tubes",
      "reason_for_recall": "Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.",
      "recall_initiation_date": "20170317",
      "center_classification_date": "20170518",
      "termination_date": "20210824",
      "report_date": "20170524",
      "code_info": "Lot #: D301311473, D301411473, Exp 3/2017",
      "more_code_info": ""
    }
  ]
}