{
  "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": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022387"
        ],
        "brand_name": [
          "TYVASO"
        ],
        "generic_name": [
          "TREPROSTINIL"
        ],
        "manufacturer_name": [
          "United Therapeutics Corporation"
        ],
        "product_ndc": [
          "66302-206"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TREPROSTINIL"
        ],
        "rxcui": [
          "857795",
          "857799"
        ],
        "spl_id": [
          "5e5649be-a5bb-4f39-9b52-c5e0bad4dc01"
        ],
        "spl_set_id": [
          "cbc31ab1-a80f-4b50-a3b1-39910b0fb609"
        ],
        "package_ndc": [
          "66302-206-01",
          "66302-206-02",
          "66302-206-03",
          "66302-206-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175416",
          "M0017817",
          "N0000009909"
        ],
        "pharm_class_epc": [
          "Prostacycline Vasodilator [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins I [CS]"
        ],
        "pharm_class_pe": [
          "Vasodilation [PE]"
        ],
        "unii": [
          "RUM6K67ESG"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80834",
      "recalling_firm": "United Therapeutics Corp.",
      "address_1": "55 Tw Alexander Dr",
      "address_2": "N/A",
      "postal_code": "27709",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "IL, PA",
      "recall_number": "D-1188-2018",
      "product_description": "Tyvaso Inhalation System Patient  a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099  RX Only.  Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709",
      "product_quantity": "2801 devices",
      "reason_for_recall": "Defective Delivery System: Water ingress through the lower water cup sensor of the device.",
      "recall_initiation_date": "20180814",
      "center_classification_date": "20180912",
      "termination_date": "20191030",
      "report_date": "20180919",
      "code_info": "Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b) Lot # 2101504, EXP 4/24/2021; 2101509, 2101522, EXP 5/8/2021; 2101531, EXP 5/15/2021; 2101534, EXP 6/10/2021; 2101543, EXP 6/14/2021; 2101558, EXP 7/26/2021"
    }
  ]
}