Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral…
Medicine recall D-1423-2014. Published in FDA’s Enforcement Report on Jul 16, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 16, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 188 Units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
188 Units, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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 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…
FDA’s list runs to 2,974 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Fl, TX.
These words name no state.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 28, 2014.
- FDA classified it on Jul 7, 2014.
- FDA’s Enforcement Report published it on Jul 16, 2014.
- FDA terminated it on Oct 24, 2014.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- United Therapeutics Corp., of Research Triangle Park, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,974 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.