WASHINGTON, D.C. — The Food and Drug Administration (FDA) announced that Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection due to the potential for elevated endotoxin levels. This recall is specific to lot number N008235 and is being conducted at the consumer level.
The use of heparin with elevated endotoxin levels could lead to severe health consequences, including febrile reactions, toxic shock, multi-organ failure, and even death. However, to date, Baxter has not received any reports of adverse events related to this issue.
Heparin Sodium in Sodium Chloride Injection is used as an anticoagulant to maintain catheter patency. The affected product is packaged in 2,000 USP units per 1,000 mL, contained in VIAFLEX Plus Plastic Containers, with each unit individually pouched. The impacted lot was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers, and distributors across the United States.
Baxter has initiated an Urgent Drug Recall communication to all impacted customers and is coordinating the return of the affected products. Customers are advised to follow the instructions in the recall letter to return the product. For questions regarding this recall, customers can contact Baxter Healthcare Center for Service at (888) 229-0001 between 7:00 a.m. and 6:00 p.m. Central Time, Monday through Friday.
Any product quality complaints or adverse events can be reported via the following options:
• Baxter Product Surveillance: Visit the Baxter product feedback portal at Baxter Product Feedback Portal or email corporate_product_complaints_round_lake@baxter.com.
• FDA MedWatch Adverse Event Reporting:
• Download the form or call 1-800-332-1088 to request a reporting form. Complete and return it to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
The FDA emphasizes that any adverse events should also be reported immediately.
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