Public advisory - Unauthorized Kobayashi eye washes and Sante FX eye drops seized from "Kiokii and…" store in Mississauga, ON, and removed from website because they may pose serious health risks

OTTAWA, ON, May 12, 2023 /CNW/ - 

Brand: 
Kobayashi 
Sante FX

Kobayashi 9 Vitamins (Black) (CNW Group/Health Canada)

Kobayashi AL Pollen Allergies (Green) (CNW Group/Health Canada)

Kobayashi Cool (Light Blue) (CNW Group/Health Canada)

Kobayashi Non-Coolin (Turquoise/Light Blue) (CNW Group/Health Canada)

Kobayashi Repair (Blue) (CNW Group/Health Canada)

Sante FX Neo (CNW Group/Health Canada)

Summary

• Product: Unauthorized health products labelled to contain prescription drugs
• Issue: Health products – Product safety
• What to do: Do not use these products. Return them to your local pharmacy for proper disposal. Consult a health care professional if you have used any of these products and have health concerns. Buy only authorized health products. Prescription drugs can only be legally sold to consumers in Canada with a prescription. Buy your prescription drugs from licensed pharmacies only.

Images

Affected products

Product	Prescription drug on the label
Kobayashi 9 Vitamins (Black)	Labelled in Japanese to contain aminocaproic acid
Kobayashi AL Pollen Allergies (Green)	Labelled in Japanese to contain aminocaproic acid
Kobayashi Cool (Light Blue)	Labelled in Japanese to contain aminocaproic acid
Kobayashi Non-Coolin (Turquoise/Light Blue)	Labelled in Japanese to contain aminocaproic acid
Kobayashi Repair (Blue)	Labelled in Japanese to contain aminocaproic acid
Sante FX Neo	Labelled to contain aminocaproic acid and neostigmine methylsulfate

Issue

Health Canada is warning consumers about unauthorized Kobayashi eye washes and Sante FX eye drops seized from the store "Kiokii and…" (actual store name) in Mississauga (719 Central Pkwy W, Suite 211), Ontario, and removed from online sale. The products were seized because they are unauthorized and labelled to contain prescription drug ingredients and may pose serious health risks.

Selling unauthorized health products in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks. For example, they could contain high-risk ingredients, such as prescription drugs, additives or contaminants that may or may not be listed on the label. These ingredients could interact with other medications and foods. In addition, these products may not actually contain the active ingredients that consumers would expect them to contain to help maintain and improve their health.

Prescription drugs should only be used under the advice and supervision of a health care professional because they are used to treat specific conditions and may cause serious side effects.

What you should do

• Do not use these products. Return the product to your local pharmacy for proper disposal.
• Consult a health care professional if you have used any of these products and have health concerns.
• Buy your prescription drugs only from licensed pharmacies.
• Buy only authorized health products. 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-related side effects or complaints to Health Canada.

Background           

Aminocaproic acid 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.

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.

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SOURCE Health Canada

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