Importation of US-Authorized BESREMi (Ropeginterferon alfa-2b-njft) Injection Due to the Current Shortage of Canadian-Authorized PEGASYS (Peginterferon alfa-2a) Injection
In plain language
This recall involves US-authorized BESREMi (Ropeginterferon alfa-2b-njft) injection, imported due to a shortage of PEGASYS. It's being recalled because of potential differences in dosage, labelling, and packaging compared to Canadian-authorized products. Patients should discuss any concerns with their healthcare professional.
What to do
- Discuss any questions or concerns with your healthcare professional.
- Follow your healthcare professional's guidance on proper use.
- Report any side effects promptly.
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Affected products
BESREMi (ropeginterferon alfa-2b-njft) injection
Model: NDC: 73536-500-01
Why this matters
Dosage, labelling, and packaging issues
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: 73536-500-01
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?
Dosage, labelling, and packaging issues
What should consumers do?
Discuss any questions or concerns with your healthcare professional. Follow your healthcare professional's guidance on proper use. Report any side effects promptly.
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. Dosage, labelling, and packaging issues
When was this product recalled?
This product was recalled on March 17, 2025.
Is the BESREMi brand affected by this recall?
Yes, BESREMi products are affected by this recall. This recall involves US-authorized BESREMi (Ropeginterferon alfa-2b-njft) injection, imported due to a shortage of PEGASYS. It's being recalled because of potential differences in dosage, labelling, and packaging compared to Canadian-authorized products. Patients should discuss any concerns with their healthcare professional.