COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels
In plain language
This recall involves COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine sold in Canada. It's being recalled because some vials and cartons have English-only labels, missing important Canadian-specific information. This could lead to medication errors if healthcare professionals do not consult the full product monograph.
What to do
- Healthcare professionals should consult the Canadian Product Monograph for complete product information.
- Access Canadian-specific labelling information at CVDvaccine.ca or by scanning the QR code on the English-only carton labels.
- This information is also available on the federal government’s covid-vaccine.canada.ca website and pfizer.ca.
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Affected products
COMIRNATY Original & Omicron BA.4/BA.5 (COVID-19 mRNA Vaccine, Bivalent [Original and Omicron BA.4/BA.5])
Model: DIN: 02531461
Why this matters
Medication error due to labelling
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: DIN: 02531461
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?
Medication error due to labelling
What should consumers do?
Healthcare professionals should consult the Canadian Product Monograph for complete product information. Access Canadian-specific labelling information at CVDvaccine.ca or by scanning the QR code on the English-only carton labels. This information is also available on the federal government’s covid-vaccine.canada.ca website and pfizer.ca.
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. Medication error due to labelling
When was this product recalled?
This product was recalled on October 7, 2022.
Is the COMIRNATY brand affected by this recall?
Yes, COMIRNATY products are affected by this recall. This recall involves COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine sold in Canada. It's being recalled because some vials and cartons have English-only labels, missing important Canadian-specific information. This could lead to medication errors if healthcare professionals do not consult the full product monograph.