FDA MedWatch - One Lot of Heparin Sodium 0.9% Sodium Chloride Injection by Baxter

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TOPIC: One Lot of Heparin Sodium 0.9% Sodium Chloride Injection by Baxter: Recall - Due to Potential for Elevated Endotoxin Levels

AUDIENCE: Patients, Health Providers, Risk Manager, Pharmacy

ISSUE: Baxter is recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.

Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death.

This issue affects one lot of product code that was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers and distributors in the United States. 

To date, Baxter has not received any reports of adverse events related to this issue.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency.

RECOMMENDATIONS:

• Customers should follow the instructions in the Urgent Drug Recall letter to return the affected product.

• Customers with questions regarding this recall should contact Baxter Healthcare Center for Service at (888)-229-0001.

• Any product quality complaints or adverse events experienced with the use of these products may be reported using one of the following options.

  • Contacting Baxter Product Surveillance at the Baxter product feedback portal at https://productfeedback.baxter.comExternal Link Disclaimer or emailing Baxter at corporate_product_complaints_round_lake@baxter.com.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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