Class I · High risk
Treprostinil Injection
Presence of Particulate Matter.
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (Treprostinil)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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
Affected NDC
66302-0206-01
Compare with the code on your package — it is the most precise check available.
Drug: Treprostinil
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tyvaso treprostinil NDC 66302-0206 |
1.74 mg/2.9mL | Inhalant Oral |
United Therapeutics Corporation | Rx |
- Recalling firm
- United Therapeutics Corp.
- NDC code
- 66302-206-01
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1188-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Treprostinil recalls
See all
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class II · Moderate risk
Tyvaso (treprostinil)
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Other recalls by United Therapeutics Corp.
All 2018 recalls
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Class II · Moderate risk
Tyvaso (treprostinil)
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
Other packaging defect recalls from 2018
All packaging defect recalls
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Class II · Moderate risk
Omnipaque (iohexol)
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Class III · Low risk
Testosterone Topical Solution
Defective Container: Repetitive complaints received indicating pump not working.
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Container packaging defect.
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