Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium 0.9% Sodium Chloride Injection

On August 5, Baxter International Inc. announced it 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.