Distribution Of A New Presentation Of Spikevax (elasomeran) Covid-19 Vaccine (0.10 Mg/ml In 2.5 Ml Multidose Vial) With English-only Vial And Carton Labels
Summary Moderna's SPIKEVAX COVID-19 vaccine in a new formulation (0.10 mg/mL in 2.5 mL multidose vials) is being recalled across Canada because the vial and carton labels are in English only. The vaccine was distributed to healthcare facilities that may serve French-speaking populations, where bilingual labeling is required. This is a labeling issue, not a safety concern with the vaccine itself.
- Product
- SPIKEVAX (elasomeran) (0.10 mg/mL)
- Reason
- Labelling - Packaging - Product safety - COVID
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2022-06-06
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/05185cdb-c220-41fb-8149-f13a740aa811