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Health CanadaGeneral Alert

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

Publicado: 19 de octubre de 2021ID de Retiro: RA-76677Categoría: Productos de ConsumoPaís: Canadá
Canada
Safety AlertHealth CanadaCanadaCanada

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

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Descripción del Producto e Identificación

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

Additional Source Details

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Panels › 1 › Text<b>Issue:</b> Unauthorized products<BR/><b>Audience:</b> General Public<BR/><b>Category:</b> Drugs, Medical Device<BR/><b>Alert type:</b> Advisory<BR/><b>Department:</b> Health Canada<BR/>
Panels › 1 › TitleSummary
Panels › 1 › Panel Namebasic_details
Panels › 2 › Text<b>Product: </b>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).<BR/><b>Issue: </b>Health Canada seized these products from Vivian Spa in Mississauga, ON, because they are unauthorized and may pose serious health risks.<BR/><b>What to do: </b>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.<BR/>
Panels › 2 › TitleSummary
Panels › 2 › Panel Namesummary
Panels › 3 › Text 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. <p id="risk"> <strong>Botulinum toxin type A</strong> 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. <strong>Unauthorized injectable drugs</strong> 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. <strong>Unauthorized medical devices </strong>that<strong> </strong>have not been licenced for sale in Canada may not meet Health Canada’s standards for safety, effectiveness or quality.
Panels › 3 › TitleIssue
Panels › 3 › Panel Namecms_issue_problem
Panels › 4 › Text<ul> <li> 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.</li> <li> 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 <a href="https://health-products.canada.ca/dpd-bdpp/index-eng.jsp">Drug Product Database</a>, <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/licensed-natural-health-products-database.html">Licensed Natural Health Products Database</a> or <a href="https://health-products.canada.ca/mdall-limh/prepareSearch-preparerRecherche.do?type=active">Medical Devices Active Licence Listing</a>.</li> <li> Report any health product <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html">adverse events</a> or <a href="https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html">complaint</a> to Health Canada.</li> </ul>
Panels › 4 › TitleWhat you should do
Panels › 4 › Panel Namecms_who_what_consumer
Panels › 5 › Text<b>Common name:</b> Unauthorized injectable drugs and Unauthorized medical devices<br/><b>Product description:</b> <table id="tab1"> <caption> Table unauthorized injectable drugs and Unauthorized medical devices</caption> <thead> <tr> <th scope="col"> Photo</th> <th scope="col"> Product</th> <th scope="col"> <a href="#risk">Risk</a></th> </tr> </thead> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-meditoxin_s_t_4_20211019-121632_16_en.jpg" /></td> <td> <strong>Meditoxin, Purified Botulinum Toxin Type A</strong></td> <td> Unauthorized injectable drug (labelled to contain botulinum toxin type A)</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-toxta_s_t_4_20211019-121811_17_en.jpg" /></td> <td> <strong>Toxta Inj. Botulinum Toxin Type A</strong></td> <td> Unauthorized injectable drug (labelled to contain botulinum toxin type A)</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-biotine_s_t_4_20211019-122011_13_en.jpg" /></td> <td> <strong>Biotine Bayer 0.5% Vitamin H Injectable solution IM</strong></td> <td> Unauthorized injectable drug</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-mizain-voluma_s_t_4_20211019-140052_12_en.jpg" /></td> <td> <strong>Mizain Voluma with Lidocaine</strong></td> <td> Unauthorized medical device</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-ppa-mizain-hyaluronic-acid-50cc_s_t_4_20211019-122508_13_en.jpg" /></td> <td> <strong>Mizain Hyaluronic Acid 50cc</strong></td> <td> Unauthorized medical device</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-ammi_s_t_4_20211019-140350_15_en.jpg" /></td> <td> <strong>Ammi Mulkwang Capture Time PDRN</strong></td> <td> Unauthorized medical device</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-royal-premium-family_s_t_4_20211019-135455_16_en.jpg" /></td> <td> <strong>Royal Premium Family #5, Prosthesis Biomaterial with Lidocaine</strong><strong> </strong></td> <td> Unauthorized medical device</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-juvederm-voluma_s_t_4_20211019-135538_13_en.jpg" /></td> <td> <strong>Juvéderm Voluma with Lidocaine</strong></td> <td> Unauthorized medical device</td> </tr> <tr> <td> <img alt="" src="https://rsam.healthycanadians.gc.ca/recall-alert-rappel-avis//hc-sc/2021//assets//vivian-spa-mole-removal-plasma-pen_s_t_4_20211019-135841_15_en.jpg" /></td> <td> <strong>Mole Removal Plasma Pen</strong></td> <td> Unauthorized medical device</td> </tr> </table><BR/>
Panels › 5 › TitleUnauthorized injectable drugs and Unauthorized medical devices
Panels › 5 › Panel Nameproduct_1
Panels › 6 › Data › 1 › TitleMeditoxin, Purified Botulinum Toxin Type A Complex. Box of 200 units
Panels › 6 › Data › 1 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-meditoxin_s_fs_4_20211019-122238_14_en.jpg
Panels › 6 › Data › 1 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-meditoxin_s_m_4_20211019-122238_14_en.jpg
Panels › 6 › Data › 2 › TitleToxta Inj. Botulinum Toxin Type A. Box of 100 units
Panels › 6 › Data › 2 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-toxta_s_fs_4_20211019-122313_11_en.jpg
Panels › 6 › Data › 2 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-toxta_s_m_4_20211019-122313_11_en.jpg
Panels › 6 › Data › 3 › TitleBiotine Bayer 0.5% Vitamin H Injectable solution I.M. Box of 6 vials
Panels › 6 › Data › 3 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-biotine_s_fs_4_20211019-122320_13_en.jpg
Panels › 6 › Data › 3 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-biotine_s_m_4_20211019-122320_13_en.jpg
Panels › 6 › Data › 4 › TitleMizain Voluma with Lidocaine. Box of 1 unit of 1.1 mL
Panels › 6 › Data › 4 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-mizain-voluma_s_fs_4_20211019-140052_12_en.jpg
Panels › 6 › Data › 4 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-mizain-voluma_s_m_4_20211019-140052_12_en.jpg
Panels › 6 › Data › 5 › TitleMizain Hyaluronic Acid 50cc
Panels › 6 › Data › 5 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-mizain-hyaluronic-acid-50cc_s_fs_4_20211019-140228_15_en.jpg
Panels › 6 › Data › 5 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-mizain-hyaluronic-acid-50cc_s_m_4_20211019-140228_15_en.jpg
Panels › 6 › Data › 6 › TitleAmmi Mulkwang Capture Time PDRN
Panels › 6 › Data › 6 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-ammi_s_fs_4_20211019-140350_15_en.jpg
Panels › 6 › Data › 6 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-ammi_s_m_4_20211019-140350_15_en.jpg
Panels › 6 › Data › 7 › TitleRoyal Premium Family #5, Prosthesis Biomaterial with Lidocaine. Box of 2 units of 1.1 mL
Panels › 6 › Data › 7 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-royal-premium-family_s_fs_4_20211019-135455_16_en.jpg
Panels › 6 › Data › 7 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-royal-premium-family_s_m_4_20211019-135455_16_en.jpg
Panels › 6 › Data › 8 › TitleJuvéderm Voluma with Lidocaine. Box of 2 units of 1mL injectable gel
Panels › 6 › Data › 8 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-juvederm-voluma_s_fs_4_20211019-135538_13_en.jpg
Panels › 6 › Data › 8 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-juvederm-voluma_s_m_4_20211019-135538_13_en.jpg
Panels › 6 › Data › 9 › TitleMole Removal Plasma Pen
Panels › 6 › Data › 9 › Full Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-mole-removal-plasma-pen_s_fs_4_20211019-135841_15_en.jpg
Panels › 6 › Data › 9 › Thumb Url/recall-alert-rappel-avis/hc-sc/2021/assets/vivian-spa-mole-removal-plasma-pen_s_m_4_20211019-135841_15_en.jpg
Panels › 6 › TitleImages
Panels › 6 › Panel Nameimages
Panels › 7 › Text Health Canada<br /> (613) 957-2983<br /> <a href="mailto:media@hc-sc.gc.ca">media@hc-sc.gc.ca</a>
Panels › 7 › TitleMedia enquiries
Panels › 7 › Panel Namemedia_enquiries
Panels › 8 › Text (613) 957-2991<br /> 1-866 225-0709<br /> <a href="mailto:info@hc-sc.gc.ca">info@hc-sc.gc.ca</a>
Panels › 8 › TitlePublic enquiries
Panels › 8 › Panel Namepublic_enquiries
Panels › 9 › Text<b>Identification number:</b> RA-76677<BR/>
Panels › 9 › TitleIdentification number
Panels › 9 › Panel Nameid_numbers
Recall IdRA-76677
Start date1634601600
Date published-62169984000

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Unauthorized injectable drugs and medical devices seized from Vivian Spa in Mississauga, ON, may pose serious health...?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

    Recall Hazard Severity
    Caution (Class III)
    Alerta Oficial de la Agencia

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