{
  "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": "North Wales",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206388"
        ],
        "brand_name": [
          "ESTRADIOL"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-3223"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "VAGINAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "884707"
        ],
        "spl_id": [
          "c9460fad-4385-488b-8253-b7a4a44683d0"
        ],
        "spl_set_id": [
          "8cb31c7c-fba8-4201-833d-844ea1a8a4de"
        ],
        "package_ndc": [
          "0093-3223-08",
          "0093-3223-19",
          "0093-3223-97"
        ],
        "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": "79542",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "1090 Horsham Rd",
      "address_2": "N/A",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed within the United States and Puerto Rico.",
      "recall_number": "D-0620-2018",
      "product_description": "Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.",
      "product_quantity": "640,486 vaginal inserts",
      "reason_for_recall": "Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.",
      "recall_initiation_date": "20180319",
      "center_classification_date": "20180406",
      "termination_date": "20191015",
      "report_date": "20180328",
      "code_info": "Lot #: a) 33812545A, 33812546A, 33812774A, Exp. 12/2018; 33812775A, Exp. 01/2019; 33812776A, 33812777A, Exp. 05/2019; 33813786A, 33813868A, Exp. 7/2019; 33813974A, 33814058A,  Exp. 09/2019; 33814113A, Exp. 01/2019;  b) 33812547A, 33813361A,33813676A, Exp. 1/2019"
    }
  ]
}