{
  "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": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "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": "70764",
      "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",
      "recall_number": "D-0485-2015",
      "product_description": "Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8",
      "product_quantity": "720  transdermal patches",
      "reason_for_recall": "Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.",
      "recall_initiation_date": "20150225",
      "center_classification_date": "20150413",
      "termination_date": "20190226",
      "report_date": "20150422",
      "code_info": "Lot #  76476; Exp 07/16"
    }
  ]
}