Dexrazoxane for Injection recall in Canada: incorrect preparation risk
In plain language
This recall involves US-labelled Dexrazoxane for Injection distributed by Mylan Pharmaceuticals ULC in Canada. It's being recalled because it requires different preparation instructions than the Canadian-labelled product, which could lead to incorrect use. Healthcare professionals should stop using the product and follow the instructions in the official notice.
What to do
- Stop using the US-labelled Dexrazoxane for Injection immediately.
- Consult the US-labelled product information for reconstitution and dilution instructions.
- Refer to the Canadian product monograph for other important information.
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Affected products
Dexrazoxane for Injection
Model: NDC 67457-207-25
Why this matters
Incorrect preparation risk
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 model number
Model numbers are typically on the product label or packaging.
Affected models: NDC 67457-207-25
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?
Incorrect preparation risk
What should consumers do?
Stop using the US-labelled Dexrazoxane for Injection immediately. Consult the US-labelled product information for reconstitution and dilution instructions. Refer to the Canadian product monograph for other important information.
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. Incorrect preparation risk
When was this product recalled?
This product was recalled on December 1, 2020.
Is the Dexrazoxane for Injection brand affected by this recall?
Yes, Dexrazoxane for Injection products are affected by this recall. This recall involves US-labelled Dexrazoxane for Injection distributed by Mylan Pharmaceuticals ULC in Canada. It's being recalled because it requires different preparation instructions than the Canadian-labelled product, which could lead to incorrect use. Healthcare professionals should stop using the product and follow the instructions in the official notice.