{
  "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": "2026-07-08",
    "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": "87741",
      "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 the United States",
      "recall_number": "D-0336-2021",
      "product_description": "Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186  Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8",
      "product_quantity": "12060 cartons",
      "reason_for_recall": "Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.",
      "recall_initiation_date": "20210416",
      "center_classification_date": "20210420",
      "termination_date": "20241011",
      "report_date": "20210428",
      "code_info": "Lot #: 88584 Exp. 03/2022",
      "more_code_info": ""
    }
  ]
}