United Therapeutics Corp. is recalling 12 Tyvaso (treprostinil) Inhalation System Starter Kits because of manufacturing deviations that do not meet Current Good Manufacturing Practice (CGMP) standards. This recall affects the starter kit model TD-100/A which contains 1.74 mg/2.9 mL (0.6 mg/mL) of treprostinil inhalation solution. While the specific nature of the manufacturing deviation was not disclosed, products made outside of standard quality controls may not meet safety or efficacy specifications.
Deviations from manufacturing standards can compromise the quality, purity, or potency of the medication and the mechanical integrity of the delivery system. For patients with pulmonary arterial hypertension, a failure in the delivery system or medication quality could lead to inadequate treatment of their condition.
Contact healthcare provider and return product to pharmacy.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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