XOFIGO® recall in Canada: Increased fractures and deaths
In plain language
This recall involves XOFIGO® (radium Ra 223 dichloride) solution for injection sold in Canada. It's being recalled because using it with abiraterone and prednisone/prednisolone has shown an increased risk of fractures and deaths. Patients should discuss any concerns with their healthcare professional.
What to do
- Stop using the product immediately if prescribed in combination with abiraterone and prednisone/prednisolone.
- Discuss any questions or concerns with your healthcare professional.
- Report any side effects to your healthcare professional, Bayer Inc., or Health Canada.
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Affected products
XOFIGO (radium Ra 223 dichloride solution for injection)
Why this matters
Increased risk of fractures and death
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?
Increased risk of fractures and death
What should consumers do?
Stop using the product immediately if prescribed in combination with abiraterone and prednisone/prednisolone. Discuss any questions or concerns with your healthcare professional. Report any side effects to your healthcare professional, Bayer Inc., 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. Increased risk of fractures and death
When was this product recalled?
This product was recalled on November 8, 2018.
Is the XOFIGO® brand affected by this recall?
Yes, XOFIGO® products are affected by this recall. This recall involves XOFIGO® (radium Ra 223 dichloride) solution for injection sold in Canada. It's being recalled because using it with abiraterone and prednisone/prednisolone has shown an increased risk of fractures and deaths. Patients should discuss any concerns with their healthcare professional.