{
  "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": "Livonia",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076658"
        ],
        "brand_name": [
          "FLUCONAZOLE"
        ],
        "generic_name": [
          "FLUCONAZOLE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-6500",
          "0904-6501"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUCONAZOLE"
        ],
        "rxcui": [
          "197698",
          "197700"
        ],
        "spl_id": [
          "3c6a1b79-df4e-4281-959e-8f41c97b13c0"
        ],
        "spl_set_id": [
          "13184b13-e252-4b4d-a3e2-cfc4ad3d55b7"
        ],
        "package_ndc": [
          "0904-6500-06",
          "0904-6500-61",
          "0904-6501-06",
          "0904-6501-61"
        ],
        "original_packager_product_ndc": [
          "55111-144",
          "55111-146"
        ],
        "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": "77106",
      "recalling_firm": "The Harvard Drug Group",
      "address_1": "17177 N Laurel Park Dr Ste 233",
      "address_2": "",
      "postal_code": "48152-3951",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the US",
      "recall_number": "D-0688-2017",
      "product_description": "Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61",
      "product_quantity": "2,341 cartons",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20170105",
      "center_classification_date": "20170428",
      "termination_date": "20170804",
      "report_date": "20170510",
      "code_info": "Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17",
      "more_code_info": ""
    }
  ]
}