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UPDATE: February 7, 2023 One lot of APO-Amitriptyline recalled due to a nitrosamine impurity Apotex Inc. is recalling one lot of APO-Amitriptyline (lot PY1904) 10 mg tablets due to the presence of N-nitrosodimethylamine (NDMA), a nitrosamine…

Health Canada is warning that intraocular lenses are not licensed to replace a patient’s natural, healthy lens (without cataracts) and that their use for this purpose comes with risks that may outweigh the benefits. Entities such as surgical eye…

Health Canada is advising about unauthorized health products that may pose serious health risks. The table is updated when Health Canada finds unauthorized health products that are promoted for sexual enhancement, weight loss, as a workout aid, as "…

UPDATED INFORMATION – January 20, 2023 On January 10, 2023, following a Federal Court of Appeal decision, the June 24, 2021 decision of the Minister of Health on the application of the data protection provisions was restored, and a new Notice of…

Health Canada removed various unauthorized health products from sale from More to Shoppe, an online Facebook store, and from its warehouse in Edson, Alberta. The products are labelled to contain prescription drugs and may pose serious health risks.…

UPDATED INFORMATION – 2023/01/17 Neutralization data for the following SARS-CoV-2 Omicron subvariants have been added to the Canadian Product Monograph: Omicron BA.2.75.2, BF.7, BJ.1, BN.1, BQ.1, BQ.1.1, and XBB. See Table 1 (below) for a summary…

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…

OCALIVA received a Notice of Compliance with Conditions in May 2017 for the treatment of PBC, pending the results of trials to verify its clinical benefit. OCALIVA is now contraindicated for PBC patients with advanced disease, such as those with Child…

GlaxoSmithKline Consumer Healthcare ULC is recalling one lot of TUMS Peppermint Regular Strength tablets after some tablets were found to contain fragments of fibreglass and other material, including paper and aluminum foil. The product is sold in a…

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…

Health Canada is warning that ozone saunas may pose serious health risks to users and to anyone in close proximity. In Canada, ozone saunas require a medical device licence from Health Canada to be imported and sold. To date, Health Canada has not…

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…

The final results of a clinical trial conducted with XELJANZ showed higher risks of MACE, thrombosis, malignancy, serious infections and fatal events, compared to TNFi, a group of medicines that suppress the body's natural response to tumor necrosis…

EVUSHELD (tixagevimab and cilgavimab for injection) may not be effective against certain SARS-CoV-2 Omicron subvariants.   Audience Healthcare professionals including physicians, pharmacists, nursing staff and public health officials.…

Since earlier this year, supplies of various formats of non-prescription pediatric/infant and children’s acetaminophen and ibuprofen products have been limited in retail and pharmacy locations and hospitals across Canada. This shortage is due to…