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Affected lots are missing risk statements on the bottle.

Affected lots are labelled with incorrect dosage form found on the label.

Linear barcode printed on the vial label is non-functioning.

An incorrect NPN is on the primary space of the affected lot.

Lot number and expiry date on vial label of affected lots may become illegible.

Affected lots are labelled with the incorrect amount of medicinal ingredient.

An incorrect label (Venlafaxine XR 37.5 mg) is attached to some units of the affected lot which contains: Venlafaxine XR 150 mg.

Affected lots are incorrectly labelled for use in the subpopulation that is less than 4 years of age.

Affected lots may be missing the DIN and Canadian contact information on the outer label.

Affected lot is missing risk statements on the outer label; Affected lot is labelled with claims that are not compliant with its terms of market authorization; Regulated party does not hold a site licence for sale of the product in Canada.

Affected lots are incorrectly labelled for use in the pediatric subpopulation.

On December 9, 2022, Health Canada authorized a new formulation of the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory…

Health Canada authorized SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) on November 3, 2022. In order to provide rapid access to the vaccine, Moderna will distribute product vials and cartons labelled in English only with the…

The Canadian labelling for all Janus Kinase (JAK) inhibitors is being updated to include the risks of serious heart-related problems, fatal blood clots and cancer. This is being done as a precautionary measure. To date, Canadian labelling for the drugs…

Affected lot is labelled with the incorrect strength and ingredient