Tromboject 1% and 3% recall in Canada: visible particles
In plain language
This recall involves Tromboject 1% and 3% (sodium tetradecyl sulfate) sold in Canada. It's being recalled because vials may contain visible, insoluble particles that could cause serious health risks if injected. Healthcare professionals are advised to use the product only when medically necessary and with a specific filter.
What to do
- Healthcare professionals should use the product only when medically necessary.
- Administer the product with an in-line, sterile, polyethersulfone (PES) filter of 0.2 micrometer pore size.
- Report any serious or unexpected side effects to Omega Laboratories Limited or Health Canada.
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Affected products
Specific affected products are listed in the official notice.
Why this matters
Serious health risks from injected particles
Do I have this product?
This recall applies to specific products. Details are listed in the official notice.
Frequently Asked Questions
Why was this product recalled?
Serious health risks from injected particles
What should consumers do?
Healthcare professionals should use the product only when medically necessary. Administer the product with an in-line, sterile, polyethersulfone (PES) filter of 0.2 micrometer pore size. Report any serious or unexpected side effects to Omega Laboratories Limited or Health Canada.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Serious health risks from injected particles
When was this product recalled?
This product was recalled on July 17, 2018.
Is the Tromboject brand affected by this recall?
Yes, Tromboject products are affected by this recall. This recall involves Tromboject 1% and 3% (sodium tetradecyl sulfate) sold in Canada. It's being recalled because vials may contain visible, insoluble particles that could cause serious health risks if injected. Healthcare professionals are advised to use the product only when medically necessary and with a specific filter.