{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020090"
        ],
        "brand_name": [
          "FLUCONAZOLE"
        ],
        "generic_name": [
          "FLUCONAZOLE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "59762-5029",
          "59762-5015",
          "59762-5016",
          "59762-5017",
          "59762-5018",
          "59762-5030"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUCONAZOLE"
        ],
        "rxcui": [
          "197698",
          "197699",
          "197700",
          "197701",
          "310352",
          "310353"
        ],
        "spl_id": [
          "825a44a4-7ec9-4c4a-b04f-7e470831a511"
        ],
        "spl_set_id": [
          "737e0fac-a2d2-4053-a0d7-edbfb6248f69"
        ],
        "package_ndc": [
          "59762-5015-1",
          "59762-5016-1",
          "59762-5017-1",
          "59762-5018-1",
          "59762-5029-1",
          "59762-5030-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359762503015",
          "0359762501516",
          "0359762502919"
        ],
        "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": "67532",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide, Italy and Republic of South Korea",
      "recall_number": "D-1356-2014",
      "product_description": "GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977.  MADE IN INDIA.  NDC 59762-5030-1",
      "product_quantity": "4,155 bottles",
      "reason_for_recall": "Defective Container: Tamper evident ring failures discovered on some bottles.",
      "recall_initiation_date": "20140129",
      "center_classification_date": "20140530",
      "termination_date": "20170314",
      "report_date": "20140611",
      "code_info": "Lot # A358502; Exp 01/15",
      "more_code_info": ""
    }
  ]
}