Heparin Sodium Injection (Baxter) – Endotoxin Contamination (2024)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Lot # N008235, Exp 8/31/2024
Products Sold
Lot # N008235, Exp 8/31/2024
Baxter Healthcare Corporation is recalling Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1 due to Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026