Class I · High risk
Treprostinil Injection
Presence of Particulate Matter.
Tyvaso (treprostinil)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
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 (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
Drug: Treprostinil
- Recalling firm
- United Therapeutics Corp.
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1423-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 III · Low risk
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Other recalls by United Therapeutics Corp.
All 2014 recalls
Class III · Low risk
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk
TYVASO (treprostinil)
CGMP Deviations
Other packaging defect recalls from 2014
All packaging defect recalls
Class II · Moderate risk
Gentamicin Injection
Defective Container: Vials may be missing stoppers.
Class III · Low risk
Mucinex DM
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Class II · Moderate risk
Meropenem I.V. 1 g is supplied in 30 mL injection vials
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Class II · Moderate risk
Emtriva (emtricitabine)
Defective Container; leaking around the cap
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