Class I · High risk Ongoing
DOXOrubin Hydrochloride Liposome injection
Reason Presence of Particulate matter: Particulate matter identified as glass.
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
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.
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
- 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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Star recalls
See all
Class II · Moderate risk Ongoing
cimzia
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
EPINEPHRINE Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Five-Star
Reason Stability Data Does Not Support Expiry Date.
Class III · Low risk Ongoing
Pitavastatin Tablets
Reason Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.