Comirnaty Original & Omicron Ba.4/ba.5 Bivalent Vaccine With English-only Vial And Carton Labels: New Formulation For Use In Children 5 To Less Than 12 Years Of Age

Summary Pfizer is recalling COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine doses for children ages 5 to under 12 across Canada due to labeling and packaging issues with English-only vials and cartons. The recall affects this specific formulation intended for younger children. The recall involves labeling, packaging, product safety, supply, and COVID-related concerns.

Product

COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine

Reason

Labelling - Packaging - Product safety - Supply - COVID

Category

drug recall

Country

Canada

Agency

HC-DRUGS

Recall date

2022-12-09

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DRUGS

Recall details on Nibble Recalls: https://trynibble.app/recalls/5f2f5fd8-e4af-4afe-9ec2-cb00f1320ef6