Advisory - Unauthorized health products seized from Tokyo Beauty & Health Care in Richmond, B.C., may pose serious health risks

OTTAWA, ON, March 31, 2021 /CNW/ -

Summary

• Products: Multiple unauthorized health products (including eye drops, an eyewash and an acne gel) from Tokyo Beauty & Health Care in Richmond, B.C.
• Issue: Products are unauthorized and labelled to contain prescription drugs, which may pose serious health risks.
• What to do: Stop using these products. Consult your health care professional if you have used any of these products and have health concerns.

Issue
Health Canada has seized several health products—including eye drops, an eyewash and an acne gel—from Tokyo Beauty & Health Care in Richmond, British Columbia (#120, 8191 Westminster Highway), because they are unauthorized and may pose serious health risks.

According to the product labels, the products contain prescription drugs (see table below for details). Prescription drugs should be taken only under the advice and supervision of a health care professional because of the risk of interactions with other medications and side effects. Prescription drugs can only be legally sold via a prescription. 

Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, effectiveness and quality and may pose serious health risks. They may contain ingredients, additives or contaminated ingredients not listed on the label. In addition, they may lack the active ingredients Canadians would expect them to contain to help maintain and improve their health or they may contain ingredients that could interact with other medications and foods. For all of these reasons, unauthorized health products could cause serious health effects. Selling unauthorized health products in Canada is illegal.

Some of the unauthorized health products are packaged and labelled in Japanese characters. As a result, information about ingredients, usage, dosage and side effects may not be understood by all consumers.

Health Canada has previously seized unauthorized products being sold by this retailer and will continue to take action to address this illegal activity and update Canadians as needed. 

Affected products

Product	Risk
Dalacin T Gel 1% Anti-bacterial gel for acne	Labelled (in Japanese) to contain clindamycin
Kobayashi Aibon/Eyebon Eyewash ALd (dark green) Eyewash	Labelled (in Japanese) to contain aminocaproic acid
Kobayashi Aibon/Eyebon Eyewash Medicala (black) Eyewash	Labelled (in Japanese) to contain aminocaproic acid
Kobayashi Aibon/Eyebon Eyewash Mild (light green) Eyewash	Labelled (in Japanese) to contain aminocaproic acid
Santen Sante Beauteye Contact Eye drops	Labelled (in Japanese) to contain neostigmine methylsulfate
Santen Sante FX Neo (silver package) Eye drops	Labelled (in English) to contain neostigmine methylsulfate and aminocaproic acid
Santen Sante FX Neo (blue package) Eye drops	Labelled (in Japanese) to contain neostigmine methylsulfate and aminocaproic acid
Santen Sante FX Vplus (gold package) Eye drops	Labelled (in English) to contain neostigmine methylsulfate and aminocaproic acid
Santen Sante FX Vplus (red package) Eye drops	Labelled (in Japanese) to contain neostigmine methylsulfate and aminocaproic acid
Santen Sante PC Eye drops	Labelled (in Japanese) to contain neostigmine methylsulfate

What you should do

• Stop using these products. Consult your health care professional if you have used any of these products 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 whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
• Report any health product adverse events or complaints to Health Canada.

Background
Aminocaproic acid: This is a prescription drug ingredient used to decrease bleeding in various clinical situations. Exposure to aminocaproic acid in the eye may affect the eye itself, and the acid may be absorbed through the tear ducts into the blood. Side effects may include watery eyes, vision changes, headache, dizziness, nausea, muscle weakness and skin rash.

Clindamycin: In topical format (i.e., applied to the skin), this is a prescription antibiotic approved in Canada to treat bacterial infections, including those associated with acne. The product should not be used in individuals with a history of ulcerative colitis (inflamed bowel) or a history of inflamed bowel associated with antibiotic use (antibiotic-associated colitis). Side effects may include dry or scaly skin, peeling skin, a stinging or burning feeling on the skin, eye pain, itching, hives, redness and gastrointestinal symptoms (such as indigestion and gas). Safety and effectiveness in children under the age of 12 has not been established.

Neostigmine methylsulfate: There are no approved eye drops containing neostigmine methylsulfate on the Canadian market. In the past, drugs similar to neostigmine were used to treat glaucoma. These medications are no longer widely used because of the significant number of potential eye-related side effects, including blurred distance vision, frontal headaches, twitching lids, red eyes, cataracts, allergic reactions, iris cysts, retinal detachment and the potential for causing a specific type of glaucoma attack. In addition, absorption into the nose via the tear duct may cause serious cardiac and respiratory side effects.

Images:
For photos of these products, please visit the online safety alert.

Également disponible en français

SOURCE Health Canada

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