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  4. Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Elevated endotoxin levels
Company Name:
Baxter International Inc
Brand Name:
Brand Name(s)
Baxter
Product Description:
Product Description
Heparin Sodium in 0.9% Sodium Chloride Injection

Company Announcement

FOR IMMEDIATE RELEASE - DEERFIELD, Ill., AUG. 5, 2024 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level 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. To date, Baxter has not received any reports of adverse events related to this issue.

Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000 mL in VIAFLEX Plus Plastic Container-1 unit per pouch. 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. The product code and lot number can be found on the individual product and shipping carton. See the product image below for more on where this information can be found.

Product Code

Product Description

Lot Number

Expiry Date

NDC Number

2B0944 Heparin Sodium in 0.9% Sodium
Chloride Injection,
2,000 units per 1,000 mL
N008235 31-Aug-2024 0338-0433-04

Baxter voluntarily sent an Urgent Drug Recall communication to all impacted customers for the impacted lot and is arranging for the return of all affected product. 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 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

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.com or emailing Baxter at corporate_product_complaints_round_lake@baxter.com.
  • Reporting to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Investor Contact
Clare Trachtman, (224) 948-3020


Company Contact Information

Consumers:
Baxter Healthcare Center for Service
(888)-229-0001
Media:
Andrea Johnson
(224) 948-5353
media@baxter.com

Product Photos

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