Advisory - Unauthorized injectable drugs and medical devices seized from Vivian Spa in Mississauga, ON, may pose serious health risks

OTTAWA, ON, Oct. 19, 2021 /CNW/ - Summary

Meditoxin, Purified Botulinum Toxin Type A Complex. Box of 200 units (CNW Group/Health Canada)

Toxta Inj. Botulinum Toxin Type A. Box of 100 units (CNW Group/Health Canada)

Biotine Bayer 0.5% Vitamin H Injectable solution I.M. Box of 6 vials (CNW Group/Health Canada)

Mizain Voluma with Lidocaine. Box of 1 unit of 1.1 mL (CNW Group/Health Canada)

Mizain Hyaluronic Acid 50cc (CNW Group/Health Canada)

Ammi Mulkwang Capture Time PDRN (CNW Group/Health Canada)

Royal Premium Family #5, Prosthesis Biomaterial with Lidocaine. Box of 2 units of 1.1 mL (CNW Group/Health Canada)

Juvéderm Voluma with Lidocaine. Box of 2 units of 1mL injectable gel (CNW Group/Health Canada)

Mole Removal Plasma Pen (CNW Group/Health Canada)

• Product: Several unauthorized injectable drugs and medical devices for cosmetic purposes, including products labelled to contain botulinum toxin type A or hyaluronic acid (a dermal filler).
• Issue: Health Canada seized these products from Vivian Spa in Mississauga, ON, because they are unauthorized and may pose serious health risks.
• What to do: Do not use these unauthorized products. Consult your healthcare professional if you have used or have been administered these products at Vivian Spa or any other location, and have health concerns. When receiving botulinum toxin or hyaluronic acid dermal filler treatments, ask your healthcare professional to show you the product label and verify that the health product has been authorized for sale by Health Canada.

Issue

Health Canada has seized several injectable drugs and medical devices, including products labelled to contain botulinum toxin type A or hyaluronic acid from Vivian Spa, located at 11-3415 Dixie Road, Mississauga, Ontario, because they are unauthorized and may pose serious health risks. These products may have been administered as treatments for cosmetic purposes.

Selling unauthorized health 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. They may lack active ingredients, or contain ingredients, additives or contaminated ingredients not listed on the label that could interact with other medications and foods. For all these reasons, unauthorized health products could cause serious health effects.

Botulinum toxin type A is used to treat severe muscle spasms in the neck, eye and foot, as well as chronic migraines, urinary incontinence, and excessive sweating. It is also used for cosmetic purposes to treat facial wrinkling. Authorized botulinum toxin type A products should only be used under specialist supervision and only if the benefits of treatment are considered to outweigh the risks. Potential risks associated with injecting an unauthorized Botulinum toxin type A product can range from mild local paralysis to death. All products administered by injection in Canada must be authorized for sale by Health Canada.

Unauthorized injectable drugs carry significant risk due to potential for infection, scarring, allergic reaction, and poor outcomes. These products have not been assessed for safety, effectiveness or quality.

Unauthorized medical devices that have not been licenced for sale in Canada may not meet Health Canada's standards for safety, effectiveness or quality.

Affected products

Product	Risk
Meditoxin, Purified Botulinum Toxin Type A	Unauthorized injectable drug (labelled to contain botulinum toxin type A)
Toxta Inj. Botulinum Toxin Type A	Unauthorized injectable drug (labelled to contain botulinum toxin type A)
Biotine Bayer 0.5% Vitamin H Injectable solution IM	Unauthorized injectable drug
Mizain Voluma with Lidocaine	Unauthorized medical device
Mizain Hyaluronic Acid 50cc	Unauthorized medical device
Ammi Mulkwang Capture Time PDRN	Unauthorized medical device
Royal Premium Family #5, Prosthesis Biomaterial with Lidocaine	Unauthorized medical device
Juvéderm Voluma with Lidocaine	Unauthorized medical device
Mole Removal Plasma Pen	Unauthorized medical device

What you should do

• Do not use these unauthorized health products. Consult with a healthcare professional if you think you may have been administered these products at this spa and have health concerns.
• When receiving botulinum toxin or hyaluronic acid dermal filler treatments, ask your healthcare professional to show you the product label and verify that the health product has been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products are currently authorized for sale by searching Health Canada's Drug Product Database, Licensed Natural Health Products Database or Medical Devices Active Licence Listing.
• Report any health product adverse events or complaint to Health Canada.

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]