{
  "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-0450-2017",
      "product_description": "Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India",
      "product_quantity": "a) 42,984 and b) 7,764 bottles",
      "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": "a) 30 count C500224, exp 12/2016, C500846, exp 01/2017  b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017",
      "more_code_info": ""
    }
  ]
}