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.
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.
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.
Drug Recall: Sapropterin Dihydrochloride Recalled Over Potency Concerns
Drug recall: Glenmark recalls 6,528 bottles of this BP drug
Drug recall: Drugs recalled by these Indian Pharma Companies
Drug recall: Mesalamine capsules recalled Due to this reason
Drug recall: Dextroamphetamine sulfate tablets recalled Due to this reason
CDSCO Empowers Regulators, Drives Pharma Export Boom
Important Information About Pseudoephedrine in India
Pakistan: Pharma Company Faces Imprisonment and Fines for NSQ Drug
Revised Schedule M: A Game-Changer for India’s Pharmaceutical Industry
New Guidelines on Stability Studies for Medical Devices in India
USFDA Inspection: At Zydus Lifesciences with 10 observations
Pharma Industry to Achieve Global Standards with Schedule M Compliance
Isopropyl Alcohol Imports Get a Boost: Safeguard Measures Lifted in India
Lupin Receives EIR from USFDA for its Aurangabad Facility
Drug recall: Sapropterin Dihydrochloride recalled over potency concerns
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: