{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA203752"
        ],
        "brand_name": [
          "MINIVELLE"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "Noven Therapeutics, LLC"
        ],
        "product_ndc": [
          "68968-6610",
          "68968-6625",
          "68968-6637",
          "68968-6650",
          "68968-6675"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "241946",
          "242891",
          "242892",
          "248478",
          "1149632",
          "1356979",
          "1356997",
          "1357007",
          "1357009",
          "1551622"
        ],
        "spl_id": [
          "58e55d14-a9df-4814-9b60-b7c9ce37b0b7"
        ],
        "spl_set_id": [
          "6c5c47ab-28ee-11e1-bfc2-0800200c9a66"
        ],
        "package_ndc": [
          "68968-6625-8",
          "68968-6637-8",
          "68968-6650-8",
          "68968-6675-8",
          "68968-6610-8"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0447348",
          "N0000175825",
          "N0000000100"
        ],
        "pharm_class_cs": [
          "Estradiol Congeners [CS]"
        ],
        "pharm_class_epc": [
          "Estrogen [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Agonists [MoA]"
        ],
        "unii": [
          "4TI98Z838E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77466",
      "recalling_firm": "Noven Pharmaceuticals, Inc.",
      "address_1": "11960 SW 144th St",
      "address_2": "N/A",
      "postal_code": "33186-6109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within US",
      "recall_number": "D-0923-2017",
      "product_description": "Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186.  NDC: 68968-6610-8",
      "product_quantity": "14434 cartons",
      "reason_for_recall": "Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.",
      "recall_initiation_date": "20170427",
      "center_classification_date": "20170623",
      "termination_date": "20190311",
      "report_date": "20170705",
      "code_info": "Lot #:: 78618, Exp. 05/2017"
    }
  ]
}