Drug recall: 7 lots of Treprostinil injection recalled due to this reason

The drug recall is due to the potential presence of silicone particles in the medication.

The Health Master

April 27, 2024

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Last Updated on October 15, 2024 by The Health Master

Drug recall

This article addresses a critical public health concern regarding a drug recall.

If you or someone you know uses Treprostinil Injection for pulmonary arterial hypertension (PAH), it’s vital to read this information.

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What is Being drug Recalled?

Par Pharmaceutical, a subsidiary of Endo International plc, is expanding its voluntary recall of Treprostinil Injection 20mg/20mL (1mg/mL).

The drug recall is due to the potential presence of silicone particles in the medication.

Why is the Drug Recalled?

Silicone particles in an injectable medication can cause serious health risks.

These particles can:

Cause local irritation or swelling at the injection site.
Travel through the bloodstream and block blood vessels in vital organs like the heart, lungs, or brain.
Potentially lead to stroke or even death.

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Important Information for Patients:

Affected Lots: The drug recall applies to seven specific lots of Treprostinil Injection 20mg/20mL (1mg/mL) with NDC number 42023-206-01.

These lots include:

Lot 57014 (Exp. Date 04/2024)
Lot 56911 (Exp. Date 04/2024)
Lot 58528 (Exp. Date 05/2024)
Lot 58529 (Exp. Date 05/2024)
Lot 60064 (Exp. Date 07/2024)
Lot 60075 (Exp. Date 07/2024)
Lot 67939 (Exp. Date 03/2025)

Distribution: The affected lots were distributed nationwide to wholesalers and hospitals between June 16, 2022, and August 7, 2023.

What to Do:

Check the NDC number and lot number on your Treprostinil Injection.
If you have a medication from the affected lots, immediately discontinue use.
Contact your doctor to discuss alternative treatment options.
Do not return the medication to your pharmacy.

How to Report Issues:

Healthcare professionals: Report any adverse events or quality problems to the FDA’s MedWatch program.
Patients: If you experience any problems potentially related to using this medication, contact your doctor.

Additional Resources:

Inmar, Inc. Recall Hotline: 1-855-410-3565 (for information regarding the recall process)
Endo Product Information: 1-800-828-9393 (for medical or technical questions)
FDA MedWatch Program: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

Please Share This Information:

If you know someone who uses Treprostinil Injection, share this information with them to ensure their safety. Early awareness of this recall is crucial.

Disclaimer: This article is for informational purposes only and should not be construed as medical advice. Always consult with a qualified healthcare professional for personalized guidance.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.