RecallDepth
Class II Terminated

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

Company
United Therapeutics Corp.
Recall Initiated
September 11, 2017
Posted
November 29, 2017
Recall Number
D-0083-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
12 devices
Firm Location
Durham, NC, United States

Reason for Recall

CGMP Deviations

Distribution

PA

Lot / Code Info

Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019

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