ELMIRON recall in Canada: risk of pigmentary maculopathy
In plain language
This recall involves ELMIRON (pentosan polysulfate sodium) 100 mg capsules sold in Canada. It's being recalled because long-term use may cause pigmentary maculopathy, an eye condition that can harm vision. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Talk to your healthcare professional about your treatment.
- Report any changes in your vision to your healthcare professional.
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Affected products
ELMIRON (pentosan polysulfate sodium), 100 mg capsules
Why this matters
Risk of pigmentary maculopathy (eye damage)
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.
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?
Risk of pigmentary maculopathy (eye damage)
What should consumers do?
Stop using the product immediately. Talk to your healthcare professional about your treatment. Report any changes in your vision to your healthcare professional.
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. Risk of pigmentary maculopathy (eye damage)
When was this product recalled?
This product was recalled on December 15, 2020.
Is the ELMIRON brand affected by this recall?
Yes, ELMIRON products are affected by this recall. This recall involves ELMIRON (pentosan polysulfate sodium) 100 mg capsules sold in Canada. It's being recalled because long-term use may cause pigmentary maculopathy, an eye condition that can harm vision. Stop using the product and follow the return/repair steps in the official notice.