OTTAWA, March 3, 2015 /CNW/ -
The issue:
Health Canada seized a health product being injected at Art Nails Ltd., located at 751 Helmcken St., Vancouver, B.C., which appeared to be unauthorized as it contained no labelling. All products administered by injection in Canada must be authorized by Health Canada and must have approved labelling.
The store owner claimed the product was Botox that had been administered to consumers. Potential risks associated with injecting an unauthorized version of a health product such as Botox, can range from mild local paralysis to death.
Products affected:
- Product is unlabelled, see photos below
Who is affected:
Consumers who have had this product administered to them at Art Nails Ltd., 751 Helmcken St., Vancouver.
What consumers should do
- Speak to your healthcare practitioner if you were administered any injections from this Art Nails location and have health concerns related to the injection.
- Consult with your healthcare practitioner if you have any questions or concerns regarding the use of Botox.
- Report any adverse events to Health Canada.
What Health Canada is doing:
Health Canada seized the product to mitigate potential risks to consumers. Art Nails Ltd. is cooperating with Health Canada and has agreed to no longer import the product.
Health Canada is working with the Canada Border Services Agency to help prevent further importation of this product.
Background:
As the product being injected was not properly labelled and could potentially pose a risk to health, it was subject to compliance and enforcement actions by Health Canada.
Authorized Botox products should only be used under specialist supervision and only if the benefits of treatment are considered to outweigh the risks.
How to report side effects to health products to Health Canada:
- Call toll-free at 1-866-234-2345
- Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
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SOURCE Health Canada
PDF available at: http://stream1.newswire.ca/media/2015/03/03/20150303_C7862_PDF_EN_12796.pdf
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