{
  "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": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020870"
        ],
        "brand_name": [
          "COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)"
        ],
        "generic_name": [
          "ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM"
        ],
        "manufacturer_name": [
          "Noven Therapeutics, LLC"
        ],
        "product_ndc": [
          "68968-0514",
          "68968-0525"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "ESTRADIOL",
          "NORETHINDRONE ACETATE"
        ],
        "rxcui": [
          "1251493",
          "1251495",
          "1251499",
          "1251501"
        ],
        "spl_id": [
          "a8dddb67-4c56-4d1d-a4ce-83dc426d33f6"
        ],
        "spl_set_id": [
          "83198ef1-11c4-11e4-9191-0800200c9a66"
        ],
        "package_ndc": [
          "68968-0514-8",
          "68968-0525-8",
          "68968-0514-2"
        ],
        "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",
          "9S44LIC7OJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88342",
      "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-0724-2021",
      "product_description": "Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186",
      "product_quantity": "223,382 boxes",
      "reason_for_recall": "Failed Stability Specifications; out of specification for shear.",
      "recall_initiation_date": "20210730",
      "center_classification_date": "20210813",
      "report_date": "20210825",
      "code_info": "Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022"
    }
  ]
}