{
  "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": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class III",
      "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": [
          "9a0aa631-133d-406b-9d32-8a1a99af4e50"
        ],
        "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": "91771",
      "recalling_firm": "Padagis US LLC",
      "address_1": "3940 Quebec Ave N",
      "address_2": "N/A",
      "postal_code": "55427-1244",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0464-2023",
      "product_description": "Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427,  NDC: 0574-2067-27",
      "product_quantity": "43,238 cartons",
      "reason_for_recall": "Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.",
      "recall_initiation_date": "20230221",
      "center_classification_date": "20230310",
      "report_date": "20230322",
      "code_info": "Lot# SCDR, Exp 02/2024"
    }
  ]
}