The Recall Desk

Manufacturer

United Therapeutics Corp.

3 recalls in our database name United Therapeutics Corp. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2018-09-19

Of the 3 recalls from United Therapeutics Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Drugs)·D-0083-2018·2017-11-29

    United Therapeutics Recalls Tyvaso Inhalation Devices Due to Manufacturing Deviations

    United Therapeutics is voluntarily recalling 12 Tyvaso Inhalation System Starter Kits due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1423-2014·2014-07-16

    United Therapeutics Recalls Tyvaso Inhalation Systems Due to Software Defect

    United Therapeutics is voluntarily recalling Tyvaso Inhalation Systems with specific medical devices that may have incorrect software, potentially causing them to not operate as instructed.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

United Therapeutics

biotech company based in Silver Spring, Maryland, United States

Country
United States
Founded
1996

Official website

Source: Wikidata (Q21071142), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.