其 他 安 全 警 示
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| Canada: Sodium Acetate Injection, USP: Potential for the presence of particulate matter (English only) |
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Health Canada announces that Fresenius Kabi Canada Ltd. has identified visible particulate matter in certain vials of Sodium Acetate Injection, USP, 328 mg/ml from lot 6126554 during routine retention sample testing.
The distributed vials from the affected lot are not being recalled due to shortages of this product.
Particulate matter (greater than 5 microns) could potentially obstruct blood flow through capillaries. In the event that particulate matter is inadvertently injected into a patient, there is potential for patient injury, such as local inflammation, phlebitis, abscesses, granulomas in visceral organs, allergic response, infections at the injection site and/or embolization in the body.
There have been no reports of adverse events to date for the affected lot.
Healthcare professionals are advised to carefully inspect all sodium acetate injectable products before and after dilution, regardless of the lot. If particulate matter is observed, the product should not be administered. Due to shortage concerns of this product, consider clinical alternatives to sodium acetate for patients when possible and conserve the product only for medically necessary use.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/sodium-acetate-injection-usp-potential-presence-particulate-matter
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada and the United States Food and Drug Administration, and was posted on the Drug Office website on 8 Mar 2022.
Ends/Wednesday, Mar 16, 2022
Issued at HKT 15:00
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