{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New Hope",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022014"
        ],
        "brand_name": [
          "EVAMIST"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "Padagis US LLC"
        ],
        "product_ndc": [
          "0574-2067"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "728118",
          "728122"
        ],
        "spl_id": [
          "2da3b881-d6b1-4996-889b-cd882108af38"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0574-2067-27",
          "0574-2067-00"
        ],
        "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": "79334",
      "recalling_firm": "Paddock Laboratories, LLC.",
      "address_1": "3940 Quebec Ave N",
      "address_2": "",
      "postal_code": "55427-1244",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the USA.",
      "recall_number": "D-0608-2018",
      "product_description": "Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427.  NDC: 0574-2067-27",
      "product_quantity": "52,596 bottles",
      "reason_for_recall": "Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.",
      "recall_initiation_date": "20180226",
      "center_classification_date": "20180328",
      "termination_date": "20200716",
      "report_date": "20180404",
      "code_info": "Lot: MEEF Exp. 04/2020",
      "more_code_info": ""
    }
  ]
}