{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076658"
        ],
        "brand_name": [
          "FLUCONAZOLE"
        ],
        "generic_name": [
          "FLUCONAZOLE"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-143",
          "55111-144",
          "55111-145",
          "55111-146"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUCONAZOLE"
        ],
        "rxcui": [
          "197698",
          "197699",
          "197700",
          "197701"
        ],
        "spl_id": [
          "69e67aa4-a859-7ab0-79df-d9bf8489998d"
        ],
        "spl_set_id": [
          "d7fa1d79-4cd3-4a55-b74b-b31e82e616a3"
        ],
        "package_ndc": [
          "55111-143-30",
          "55111-143-01",
          "55111-143-05",
          "55111-143-79",
          "55111-143-78",
          "55111-144-30",
          "55111-144-01",
          "55111-144-05",
          "55111-144-79",
          "55111-144-78",
          "55111-145-71",
          "55111-145-12",
          "55111-146-30",
          "55111-146-01",
          "55111-146-05",
          "55111-146-79",
          "55111-146-78"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111145127"
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182140",
          "N0000182141",
          "N0000185504"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2C19 Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]"
        ],
        "unii": [
          "8VZV102JFY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76122",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0451-2017",
      "product_description": "Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12",
      "product_quantity": "59,440 blister cards",
      "reason_for_recall": "Failed Dissolution Specifications; 18 month stability time point",
      "recall_initiation_date": "20161228",
      "center_classification_date": "20170130",
      "termination_date": "20171019",
      "report_date": "20170208",
      "code_info": "C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017",
      "more_code_info": ""
    }
  ]
}