Drug recall: Baxter recalls Heparin Sodium Injection Due to this reason

This drug recall is being conducted with the full knowledge and cooperation of the U.S. Food and Drug Administration.

August 10, 2024

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Last Updated on October 15, 2024 by The Health Master

Drug recall

Baxter International Inc. is issuing a voluntary nationwide drug recall of a single lot of Heparin Sodium in 0.9% Sodium Chloride Injection due to the possibility of elevated endotoxin levels.

This drug recall prioritizes patient safety and aims to prevent potentially serious health complications.

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Detail of the drug recall

Product: Heparin Sodium in 0.9% Sodium Chloride Injection
Lot Number: N008235
Size: 2,000 USP units per 1,000 mL
Packaging: VIAFLEX Plus Plastic Container (1 unit per pouch)
Distribution Dates: March 12, 2023 – August 24, 2023

Reason for this Drug Recall:

The drug recall is due to concerns about potentially higher-than-acceptable levels of endotoxins in the affected lot (N008235).

Endotoxins are bacterial substances that can cause severe adverse reactions in patients, ranging from fever and chills to life-threatening complications like toxic shock and multiple organ failure.

What to Do if You Have the Recalled drug:

Healthcare Facilities:
- Immediately stop using the recalled lot (N008235) of Heparin Sodium in 0.9% Sodium Chloride Injection.
- Locate and quarantine any remaining stock of the affected product.
- Follow the instructions provided in Baxter’s Urgent Drug Recall communication for returning the recalled product.
Patients:
- If you have been administered Heparin Sodium from lot N008235, consult your healthcare provider immediately to discuss alternative treatment options.
- Do not use the recalled drug at home.

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How to Identify the Recalled drug:

The product code, lot number, expiry date, and NDC number are printed on both the individual product and the shipping carton.

Refer to the table below for guidance:

Information	Location
Product Code	Individual product and shipping carton
Product Description	Individual product and shipping carton
Lot Number	Individual product and shipping carton (N008235 for recalled lot)
Expiry Date	Individual product and shipping carton (August 31, 2024)
NDC Number	Individual product and shipping carton (0338-0433-04)

Baxter’s Commitment to Patient Safety

Baxter takes patient safety very seriously.

The company is actively working with healthcare providers and distributors to ensure the swift and effective return of the affected product.

This drug recall is being conducted with the full knowledge and cooperation of the U.S. Food and Drug Administration (USFDA).

Disclaimer: This article is intended for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional for any health concerns.

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.

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