Spikevax Bivalent (original / Omicron Ba.4/5) (elasomeran/davesomeran) Covid-19 Vaccine With English-only Vial And Carton Labels

Recall Summary Moderna's SPIKEVAX Bivalent COVID-19 vaccine is being recalled across Canada due to labeling issues on vials and cartons that only have English-language labels. The recall affects the specific batch of this booster vaccine formulated for the Original strain and Omicron BA.4/5 variants. The labeling problem relates to product safety and regulatory compliance requirements for pharmaceutical packaging in Canada.

Product

SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) COVID-19 Vaccine

Reason

Labelling - Packaging - Product safety - Supply - COVID

Category

drug recall

Country

Canada

Agency

HC-DRUGS

Recall date

2022-11-18

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DRUGS

Recall details on Nibble Recalls: https://trynibble.app/recalls/ede39049-cb93-4fd8-9916-bcf55bf6849d