Urgent Recall of Endotoxin contaminated Baxter Heparin in Saline

How much Endotoxin triggered the recall?

Endotoxin in the Headlines - if you look at the right news

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

Came across this by accident while researching another FDA scandal.

Note how long this contaminated product was used before the recall - since February 2023.¹

Company press release says:

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.

I wonder how many people were harmed?

FAERS reports 7,369 Deaths from Heparin Sodium Chloride

To 30 June 2024 UDS FAERS reports 7,369 Deaths from 32,824 Serious cases in a total of 39,426 Adverse Event Reports.

1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-voluntary-nationwide-recall-one-lot-heparin-sodium-09-sodium-chloride-injection-due