{
  "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": "Melville",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA076294"
        ],
        "brand_name": [
          "KETOCONAZOLE"
        ],
        "generic_name": [
          "KETOCONAZOLE"
        ],
        "manufacturer_name": [
          "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "0168-0099"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "KETOCONAZOLE"
        ],
        "rxcui": [
          "203088"
        ],
        "spl_id": [
          "6eaf555f-3e9c-4811-ae1f-66afda8b2b11"
        ],
        "spl_set_id": [
          "cad7c647-34a9-4e4e-83b3-8d78e58f588f"
        ],
        "package_ndc": [
          "0168-0099-15",
          "0168-0099-30",
          "0168-0099-60"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301680099156"
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182141",
          "N0000190115",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 3A5 Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "R9400W927I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62625",
      "recalling_firm": "Fougera Pharmaceuticals  Inc.",
      "address_1": "60 Baylis Road",
      "address_2": "N/A",
      "postal_code": "11747-0103",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-241-2013",
      "product_description": "Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15",
      "product_quantity": "60,210 units",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product",
      "recall_initiation_date": "20120718",
      "center_classification_date": "20130402",
      "termination_date": "20151210",
      "report_date": "20130410",
      "code_info": "Lot #: 835H, Exp 07/12"
    }
  ]
}