Unauthorized Nabota botulinum toxin may pose serious health risks
- Starting date:
- September 30, 2019
- Type of communication:
- Source of recall:
- Health Canada
- Unauthorized products
- General Public
- Identification number:
September 30, 2019
For immediate release
OTTAWA - Health Canada is advising consumers that an unauthorized botulinum toxin drug called Nabota Botulinum Toxin Type A may pose serious health risks. Health Canada seized the product from two Toronto area-clinics: Med-Aesthetics Headache Treatment Centre in Woodbridge, Ontario (8611 Weston Road, #19), and New You Spa in Toronto, Ontario (1920 Yonge Street, Suite 107).
The Department also seized a shipment of Nabota Botulinum Toxin Type A at the border that was destined for a second Med-Aesthetics clinic located in Brampton, Ontario (247 Main Street North, second floor), and believes that this drug was being offered at that location. The drug comes packaged in vials labelled in Korean and English (see photo) and is administered by injection.
Selling unauthorized health products in Canada is illegal. Health products that have not been authorized by Health Canada have not been assessed for safety, effectiveness and quality, and may pose serious health risks. Unauthorized health products may be contaminated, contain dangerous ingredients not listed on the label, or not contain the ingredient shown on the label.
Who is affected
Consumers who have been administered this product at these locations.
Nabota Botulinum Toxin Type A (Nabota is labelled in Korean on the vial)
What consumers should do
- Do not use this unauthorized product. Consult with a health care professional if you think you may have been administered this product at these clinics and have health concerns.
- When receiving botulinum toxin treatments, ask your health care 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 and Licensed Natural Health Products Database.
- Report any health product adverse events or complaints to Health Canada.
- Stay connected with Health Canada and receive the latest advisories and product recalls.
What Health Canada is doing
Health Canada seized the product and has requested that the clinics stop selling it. Health Canada is working with the Canada Border Services Agency to help prevent further importation of these products. Should additional safety concerns be identified, the Department will take appropriate action and inform Canadians as necessary.
Botulinum toxin type A is a prescription drug 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 be used only under the supervision of a qualified health care professional 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 range from mild local paralysis to death. All products administered by injection in Canada must be authorized for sale by Health Canada.
In addition, unauthorized injectable health products for cosmetic purposes carry significant risk because of the potential for infection, scarring and poor outcomes.
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