{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA200923"
        ],
        "brand_name": [
          "GYNAZOLE 1"
        ],
        "generic_name": [
          "BUTOCONAZOLE NITRATE"
        ],
        "manufacturer_name": [
          "Padagis Israel Pharmaceuticals Ltd"
        ],
        "product_ndc": [
          "45802-396"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "VAGINAL"
        ],
        "substance_name": [
          "BUTOCONAZOLE NITRATE"
        ],
        "rxcui": [
          "890785",
          "890786"
        ],
        "spl_id": [
          "3953738b-1476-4a24-9e07-a7d3866d76a8"
        ],
        "spl_set_id": [
          "125d8ede-db38-4eb9-a6be-19208687f36a"
        ],
        "package_ndc": [
          "45802-396-01",
          "45802-396-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4805237NP5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93189",
      "recalling_firm": "Padagis US LLC",
      "address_1": "3940 Quebec Ave N",
      "address_2": "N/A",
      "postal_code": "55427-1244",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0081-2024",
      "product_description": "Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010.  NDC: 45802-396-01",
      "product_quantity": "10,512 cartons",
      "reason_for_recall": "Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.",
      "recall_initiation_date": "20230928",
      "center_classification_date": "20231031",
      "report_date": "20231108",
      "code_info": "Lot#: 164185, Exp. Date 4/2024"
    }
  ]
}