{
  "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": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA040197"
        ],
        "brand_name": [
          "ESTRADIOL"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0555-0886",
          "0555-0899",
          "0555-0887"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "197657",
          "197658",
          "197659"
        ],
        "spl_id": [
          "e9b2e697-6e57-436a-933d-5554ca402da7"
        ],
        "spl_set_id": [
          "c4936878-1643-4e7f-9b0d-e4957935aef2"
        ],
        "package_ndc": [
          "0555-0899-02",
          "0555-0886-02",
          "0555-0886-04",
          "0555-0887-02",
          "0555-0887-04"
        ],
        "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": "89450",
      "recalling_firm": "CARDINAL HEALTHCARE",
      "address_1": "7200 Cardinal Pl W",
      "address_2": "",
      "postal_code": "43017-1094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0180-2024",
      "product_description": "ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.  NDC: 0555-0899-02",
      "product_quantity": "1 unit",
      "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
      "recall_initiation_date": "20220126",
      "center_classification_date": "20231226",
      "termination_date": "20240929",
      "report_date": "20240103",
      "code_info": "Batch 100023687",
      "more_code_info": ""
    }
  ]
}