Medicine recalls
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The United States: Baxter issues voluntary nationwide recall of one lot of Heparin Sodium 0.9% Sodium Chloride Injection due to potential for elevated endotoxin levels |
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The US Food and Drug Administration (FDA) announces that Baxter International Inc. is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection, 2,000 units per 1,000 mL (lot number: N008235) to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to the affected lot.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-voluntary-nationwide-recall-one-lot-heparin-sodium-09-sodium-chloride-injection-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Aug 7, 2024
Issued at HKT 15:30
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