D-0083-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2017
- Initiation Date
- September 11, 2017
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
Product Description
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
Reason for Recall
CGMP Deviations
Distribution Pattern
PA
Code Information
Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019