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. Inadvertent injection of particulate matter could result in serious risks to patient health.
What to do
- This recall is for healthcare professionals.
- Administer Tromboject 1% and 3% with sterile medical grade polyethersulfone (PES) filters of 0.22 micrometer pore size, and 25 or 33 mm diameter.
- Limit use to medically necessary interventions or when there are no therapeutic alternatives.
- Report any suspected adverse reactions to Omega Laboratories Limited or Health Canada.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Tromboject 1% Inj 10mg/mL Sodium Tetradecyl Sulfate
Lot: L0010049
Tromboject 3% Inj 30 mg/mL Sodium Tetradecyl Sulfate
Lot: L0010050, L0010051
Why this matters
Serious risks to patient health from particulate matter
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: L0010049, L0010050, L0010051
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Serious risks to patient health from particulate matter
What should consumers do?
This recall is for healthcare professionals. Administer Tromboject 1% and 3% with sterile medical grade polyethersulfone (PES) filters of 0.22 micrometer pore size, and 25 or 33 mm diameter. Limit use to medically necessary interventions or when there are no therapeutic alternatives. Report any suspected adverse reactions 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 risks to patient health from particulate matter
When was this product recalled?
This product was recalled on September 12, 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. Inadvertent injection of particulate matter could result in serious risks to patient health.