Public recall detail

Authorization of Janssen COVID-19 Vaccine with English-only Vial and Carton Labels

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Recall Safety notice
Quick summary

Quick summary: Authorization of Janssen COVID-19 Vaccine with English-only Vial and Carton Labels .

Recommended action

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Recall details

Quick summary: Authorization of Janssen COVID-19 Vaccine with English-only Vial and Carton Labels .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

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Issue

Janssen COVID-19 Vaccine was authorized for use in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. As an extraordinary measure to provide earlier access to vaccine supplies in the context of the global pandemic, Janssen Inc. is providing, at this time, vaccine vials and cartons labelled with the global label. This label is presented in English-only and is missing some important Canadian-specific information normally found on Health Canada approved labels, including the expiration date (see the Information for healthcare professionals section).

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