Tyvaso Inhalant
FDA Recall NDC 66302-206
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tyvaso (NDC 66302-206). A significant event, classified as Class III, was initiated on Aug 14, 2018 by United Therapeutics Corporation. The reported reason for this action was: "Defective Delivery System: Water ingress through the lower water cup sensor of the device."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Aug 14, 2018
Sep 19, 2018
2801 devices
Recall Profile & Regulatory Data
Event ID
80834
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
United Therapeutics Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
IL, PA
Termination Date
Oct 30, 2019
Product Description
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709
Batch or Lot Expiration Information
Lot# Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b)
Lot# 2101504, EXP 4/24/2021; 2101509, 2101522, EXP 5/8/2021; 2101531, EXP 5/15/2021; 2101534, EXP 6/10/2021; 2101543, EXP 6/14/2021; 2101558, EXP 7/26/2021
Affected Packages Involved in this Recall
66302-206-01Product
66302-206-02Product
66302-206-03Product
66302-206-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
