{
  "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 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": "80997",
      "recalling_firm": "Noven Pharmaceuticals, Inc.",
      "address_1": "11960 SW 144th St",
      "address_2": "",
      "postal_code": "33186-6109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1209-2018",
      "product_description": "Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8",
      "product_quantity": "26217 boxes of 8 patches",
      "reason_for_recall": "Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.",
      "recall_initiation_date": "20180907",
      "center_classification_date": "20180925",
      "termination_date": "20200909",
      "report_date": "20181003",
      "code_info": "Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019",
      "more_code_info": ""
    }
  ]
}