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Safety Report: Baxter Heparin Sodium Chloride Injection - recalled due to elevated endotoxin levels, USA
3 months ago •source fda.gov
Recall notice
United States
Baxter International Inc. 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. This issue affects one lot of product codes that were distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers, and distributors in the United States.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.
The product recalled is Heparin Sodium in 0.9% Sodium Chloride Injection, 2,000 units per 1,000 mL, Product Code: 2B0944, Lot Number: N008235, Expiry Date: 31-Aug-2024, NDC: 0338-0433-04. The product code and lot number can be found on the individual product and shipping carton.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Baxter International Inc
Brand name: Baxter
Product recalled: Heparin Sodium in 0.9% Sodium Chloride Injection
Reason of the recall: Elevated endotoxin levels
FDA Recall date: August 06, 2024
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-voluntary-nationwide-recall-one-lot-heparin-sodium-09-sodium-chloride-injection-due
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