Unauthorized "Botulax" injection and medical sutures seized from SPMU-MTS Studio in Richmond, BC

Starting date:

March 31, 2017

Type of communication:

Advisory

Subcategory:

Drugs, Medical Device

Source of recall:

Health Canada

Issue:

Unauthorized products

Audience:

General Public

Identification number:

RA-62866

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Issue

Health Canada is advising Canadians that it has seized the unauthorized injectable health product “Botulax” and unauthorized medical sutures “The Lift II” from SPMU-MTS Studio, at 8788 McKim Way, Unit 1200, in Richmond, BC. Both products may pose serious risks to the health of Canadians.

Botulax is labelled to contain botulinum toxin type A and was being administered as an injectable treatment for cosmetic purposes. The Lift II is an absorbable suture used to close incisions after surgery. Neither product is authorized for sale in Canada, which means they have not been assessed for safety, effectiveness or quality.

Products affected

• Botulax
• The Lift II

What you should do

• Consult with your health care professional if you received any Botulax injections or if you have undergone any procedures using The Lift II sutures at this location and have health concerns.
• Read product labels to verify that health products have 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 if products have been authorized for sale by searching Health Canada’s Drug Product Database, Licensed Natural Health Product Database or Medical Devices Active Licence Listing (MDALL).
• Report adverse events to health products to Health Canada by calling toll-free at 1 866 234 2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1 800 267 9675, or complete an online complaint form.

Who is affected

• Consumers who have received injections of Botulax or who have undergone procedures using The Lift II sutures at this location.

Background

Botulinum toxin type A is used to treat severe muscle spasms in the neck, eye and foot, as well as chronic migraines, 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.

The Lift II is an absorbable suture used to close incisions after surgery. It is not authorized for sale in Canada. The safety, effectiveness or quality of unauthorized medical devices is not known, and unauthorized medical devices may pose serious risks to the health of Canadians.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Health Canada seized the products from SPMU-MTS Studio. Health Canada is working with the Canada Border Services Agency to help prevent further importation of these products. Should additional products, retailers or distributors be identified, Health Canada will take appropriate action and inform Canadians as necessary.

Images

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