{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Research Triangle Park",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Drugs",
      "event_id": "67892",
      "recalling_firm": "United Therapeutics Corp.",
      "address_1": "55 Tw Alexander Dr",
      "address_2": "P.O. Box 14186",
      "postal_code": "27709-0152",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Fl, TX.",
      "recall_number": "D-1423-2014",
      "product_description": "Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709",
      "product_quantity": "188 Units",
      "reason_for_recall": "Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.",
      "recall_initiation_date": "20140328",
      "center_classification_date": "20140707",
      "termination_date": "20141024",
      "report_date": "20140716",
      "code_info": "Lot #s:   TD-100: PCBA Lot 60  TD-100: PCBA Lot 61  TD-100: PCBA Lot 62  TD-100: PCBA Lot 63  Optineb: PCBA Lot 72  Optineb: PCBA Lot 73    SERIAL NUMBERS:    Kit S/N  ML 1897  ML 1898  ML 1894  ML 1895  ML 1896    TD-100 S/N's   23103954 23103976 23104015 23104017 23104006   23104000 23103995  23104018 23104016    Optineb devices shipped to Caremark:  Kit S/N  ML 3660  MP 3662  ML 3665  MP 3667  MP 3668  MP 3676  MP 3683  MP 3690  ML 3691  MP 3692    Optineb S/N's   20900207 20900212 20900219 20900222 20900226  20900209 20900213  20900225 20900227     20900241 20900310 20900295 20900293 20900291                      20900240 20900308 20900294 20900292 20900290    Kit S/N 3697  MP 3698  ML 3699  MP 3700  MP 3708  MP  Optineb S/N's     20900262 20900283 20900285 20900265 20900253   20900264 20900284 20900286 20900268 20900315    NPR \u0013 Device Not Part of Recall  MP=Mount Prospect; ML-Monroeville    TD-100 devices shipped to Accredo:  Kit S/N   1879 1880 1881 1882 1883 1884 1885 1886 1887  TD-100 S/N's     23103982 23103985 23103988 23103990 23103992  23103984 23103986 23103989 23103991 23103993     23103959 23103961 23103963 23103994                      23103958 23103960 23103962 23103972    Kit S/N                       1888 1889 1890 1891 1892 1893 1899 1900 1901  TD-100 S/N's   23103970 23103997 23103996 23104022 23104019  23103975 23103998 23103999 23104024 23104020     23104014 23103981 23103980 23103974                      23104013 23103978 23103973 23103964    Kit S/N   1902 1903 1904 1905 1906 1907 1908 1909 1910  TD-100 S/N's     23103966 23103968 23103956 23103952 23103950  23103967 23103977 23103957 23103955 23103951     23103948 23103945 23103941                       23103943 23103942 23103940 23103944    Kit S/N   1911 1912 1913 1914 1916 1917 1918 1919 1921  TD-100 S/N's   23103947 23103949 23103939 23103946 23104001   23103965 23103969  23104002     23104005                       23104003 23104011 23104007 23104008    TD-100 devices shipped to Accredo (continued):    Kit S/N   1922 1923 1933 1934  TD-100 S/N's   23104012 23104009 23103937 23103938   23104025 23104010     Kit S/N   1935 1939 2175 2176 2178 2212 2227 2228  TD-100 S/N's   23104030 23104027 23101851 23103987 23103971   23104028   23103700     23103608 23103979 23103334                      23103439 23101566 23103672    Kit S/N   2229 2311 2364 2481 2491  TD-100 S/N's   23103686 23103684 23104026 23104029 23104004      \u0003    Optineb devices shipped to Accredo:  Kit S/N   3658 3659 3661 3669 3670 3672 3674 3675 3680  Optineb S/N's   20900203 20900205 20900210 20900228 20900230  20900204 20900206 20900211 20900229 20900231 20900235 20900223 20900239 20900252                      20900236 20900202 20900224 20900250    Kit S/N   3681 3682 3687 3694 3696 3702 3703 3704  Optineb S/N's   20900249 20900311 20900298 20900256 20900260  20900254 20900312 20900300 20900257 20900261 20900273 20900275 20900277                      20900272 20900274 20900276      Optineb devices shipped to Curascript:  Kit S/N 3657 3666 3671 3673 3677 3679 3685 3686 3689  Optineb S/N's   20900200 20900220 20900232 20900237 20900242  20900201 20900221 20900234 20900238 20900243 20900247 20900305 20900302 20900297                      20900246 20900304 20900301 20900296    Kit S/N 3693 3701 3706 3709  Optineb S/N's   20900255 20900269 20900281 20900313   20900282 20900270 20900287 20900314",
      "more_code_info": ""
    }
  ]
}