ISTODAX (romidepsin) recall in Canada: Product withdrawal
In plain language
This recall involves ISTODAX (romidepsin) lyophilized powder for solution, sold in Canada. It is being withdrawn from the market because a study failed to confirm its clinical benefit when used with chemotherapy. Patients currently using ISTODAX should discuss their treatment with a healthcare professional.
What to do
- Discuss with your healthcare professional whether to continue treatment with ISTODAX.
- Enroll in the Restricted Access Program if you will continue to receive ISTODAX.
- Do not initiate ISTODAX if you are a new patient.
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Affected products
ISTODAX (romidepsin); Lyophilized powder for solution; 10 mg/vial; Intravenous infusion
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?
This recall involves ISTODAX (romidepsin) lyophilized powder for solution, sold in Canada. It is being withdrawn from the market because a study failed to confirm its clinical benefit when used with chemotherapy. Patients currently using ISTODAX should discuss their treatment with a healthcare professional.
What should consumers do?
Discuss with your healthcare professional whether to continue treatment with ISTODAX. Enroll in the Restricted Access Program if you will continue to receive ISTODAX. Do not initiate ISTODAX if you are a new patient.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on March 20, 2023.
Is the ISTODAX brand affected by this recall?
Yes, ISTODAX products are affected by this recall. This recall involves ISTODAX (romidepsin) lyophilized powder for solution, sold in Canada. It is being withdrawn from the market because a study failed to confirm its clinical benefit when used with chemotherapy. Patients currently using ISTODAX should discuss their treatment with a healthcare professional.