SPIKEVAX (elasomeran) COVID-19 Vaccine recall in Canada: labelling issue
In plain language
This recall involves a new presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) distributed in Canada. It's being recalled because the vials and cartons have English-only labels, missing important Canadian-specific information. Healthcare professionals should refer to the official notice for complete product information.
What to do
- Refer to the official notice for complete product information.
- Access Canadian-specific labelling information online.
- Pay careful attention to vial labels, cap colour, and dose volumes.
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Affected products
SPIKEVAX (elasomeran) (0.10 mg/mL), dispersion for intramuscular injection, multidose vial (2.5 mL), royal blue vial cap
Model: DIN: 02527685
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: 02527685
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 a new presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) distributed in Canada. It's being recalled because the vials and cartons have English-only labels, missing important Canadian-specific information. Healthcare professionals should refer to the official notice for complete product information.
What should consumers do?
Refer to the official notice for complete product information. Access Canadian-specific labelling information online. Pay careful attention to vial labels, cap colour, and dose volumes.
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 June 6, 2022.
Is the SPIKEVAX brand affected by this recall?
Yes, SPIKEVAX products are affected by this recall. This recall involves a new presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) distributed in Canada. It's being recalled because the vials and cartons have English-only labels, missing important Canadian-specific information. Healthcare professionals should refer to the official notice for complete product information.