Recall MonitorUnauthorized injectable health products sold online and seized from Dyosa Beauty & Wellness Lounge in Hamilton, ON, may pose serious health risks
· Published by Health Canada · Official notice
Details
Images
Products
| Category | Product |
|---|---|
| Unauthorized injectable drug | Botox cosmetic for injection (1 photo) Huons ascorbic acid injection (labelled in English and a foreign language) (2 photos) Laennec injection (placenta product, labelled in English and a foreign language) (2 photos) Lemon bottle ampoule solution (labelled for topical use [applied to the skin] but containing vials for injection) (1 photo) |
| Counterfeit injectable medical device | Juvéderm Ultra 3 (1 photo) Juvéderm voluma with lidocaine (1 photo) Restylane Kysse injectable gel with lidocaine (hyaluronic acid) (1 photo) |
Issue
Health Canada has seized several unauthorized injectable health products—including counterfeit medical devices—from Dyosa Beauty & Wellness Lounge (45 Wellington St. N.) in Hamilton, Ontario, because they may pose serious health risks. Unauthorized health products were also advertised for sale through the business' social media accounts. Many of the seized unauthorized injectable health products are used for cosmetic purposes. They include injectable drugs and medical devices (such as dermal fillers). Selling unauthorized health products—including counterfeit products—in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means they have not been assessed for safety, effectiveness and quality and may pose serious health risks. For example, they may lack active ingredients, vary in their concentration or contain ingredients, additives or contaminated ingredients not listed on the label that could interact with other medications and foods. Counterfeit health products are imitations of authentic products, but they are not the same and may pose serious health risks. The manufacturers of the authentic versions of the seized medical devices have confirmed that they are counterfeit. Unauthorized injectable health products carry additional significant risks, including infections, scarring, allergic reactions, and other serious adverse outcomes due to contamination, improper handling, or unsafe administration. Several of the health products seized are not labelled in English and French as required in Canada. As a result, information about ingredients, usage, dosage and side effects may not be available to or understood by consumers. Health Canada will act to protect public health and safety when companies are found to be selling unauthorized health products in Canada, including warning consumers when warranted. The Department also works with the Canada Border Services Agency to help prevent the import of any unauthorized health products.