{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA079193"
        ],
        "brand_name": [
          "MIMVEY"
        ],
        "generic_name": [
          "ESTRADIOL AND NORETHINDRONE ACETATE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-5455"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESTRADIOL",
          "NORETHINDRONE ACETATE"
        ],
        "rxcui": [
          "1359126",
          "1359127",
          "1359129"
        ],
        "spl_id": [
          "2704fcb9-da21-461e-b6ba-b196b2f2bf4b"
        ],
        "spl_set_id": [
          "b1c5c06b-9ce2-4bf7-9693-e37608055a14"
        ],
        "package_ndc": [
          "0093-5455-28",
          "0093-5455-42"
        ],
        "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": "89368",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "400 Interpace Pkwy",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0521-2022",
      "product_description": "Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28",
      "product_quantity": "218174 cartons",
      "reason_for_recall": "Mislabeling",
      "recall_initiation_date": "20220107",
      "center_classification_date": "20220202",
      "termination_date": "20230601",
      "report_date": "20220209",
      "code_info": "Lot#: 100018611, Exp 03/2022; 100019834, Exp 06/2022; 100022226, Exp 09/2022; 100024574, Exp 01/2023"
    }
  ]
}