TYVASO Inhalation Solution Treprostinil 1 recalled over manufacturing violations
- Recall date
- September 11, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- United Therapeutics Corp. recalls TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit…
- Recall number
- D-0083-2018
- FDA classification
- Class II
- Brand / firm
- United Therapeutics Corp.
- Sold / distributed
- PA
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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