September 2017 FDA Recall Drug by United Therapeutics Corp.
D-0083-2018 - CGMP Deviations
This Class II drug recall was voluntarily initiated by United Therapeutics Corp. on September 11, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in PA and the recall is currently terminated.
Recall Number: D-0083-2018
CGMP Deviations
09-11-2017
11-29-2017
12 devices
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
United Therapeutics Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
PA
04-03-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 2101152; Exp. 12/11/2017
Lot# : 2101195; Exp. 04/26/2019
