Unauthorized prescription product "Kobayashi Eyebon Eyewash" seized at Catwalk Boutique in Burnaby may pose serious health risks

Starting date:

August 25, 2017

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-64326

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

Issue

Health Canada is advising consumers that the unauthorized prescription product “Kobayashi Eyebon Eyewash” may pose serious health risks. The product is labelled to contain the prescription drug, aminocaproic acid, and is promoted as an eyewash for contact lens users and for the prevention of eye disease. The product, sold in three formats (Cool, Mild and Regular), was seized at the Catwalk Boutique retail location in Burnaby, B.C. (1313 – 4500 Kingsway). The product was also being sold online (www.ac-beauty.com/shop) and at the Catwalk Boutique retail location in Richmond, B.C. (2005 - 4000 No.3 Rd.).

The unauthorized health product was packaged and labelled in Japanese. As a result, information about ingredients, usage, dosage and side effects may not be understood by all consumers. Products that contain prescription drug ingredients should only be taken under the supervision of a health professional because they are used to treat specific diseases, and may cause serious side effects.

Products affected

Kobayashi Eyebon Eyewash: Cool, Mild and Regular.

What you should do

• Stop using this product. Consult with your health care professional if you have used it 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 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 bought or used any of the three Kobayashi Eyebon Eyewash formats: Cool, Mild and Regular.

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 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.

The affected product has not been approved by Health Canada. This means that it has not been assessed for safety, effectiveness and quality. As a result, it may contain ingredients, additives, or contaminated ingredients not listed on the label. In addition, it may lack the active ingredients Canadians would expect it to contain to help maintain and improve their health, or it may contain ingredients that may interact with other medications and foods. For all of these reasons, it could cause serious health effects.

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 unauthorized product from the Burnaby retail location. The company has confirmed that it has stopped selling it online and at the Richmond retail location. Should additional retailers or distributors be identified, Health Canada will take appropriate action and inform Canadians as necessary.

Images

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