Multiple unauthorized eye solutions and an acne gel sold at two stores in the Lower Mainland of BC may pose serious health risks

Starting date:: April 15, 2019
Type of communication:: Advisory
Subcategory:: Drugs
Source of recall:: Health Canada
Issue:: Unauthorized products, Important Safety Information
Audience:: General Public
Identification number:: RA-69608

Last updated: 2019-04-15

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

April 15, 2019
For immediate release

OTTAWA - Health Canada is advising consumers that multiple health products-including eye drops, an eyewash and an acne gel―being sold at two Burnaby and Richmond stores in British Columbia are unauthorized and may pose serious health risks. According to the product labels, these health products contain prescription drugs. Prescription drugs should be taken only under the advice and supervision of a healthcare professional because they are used to treat specific diseases and may cause serious side effects.

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.

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-related adverse reactions or complaints to Health Canada.

Who is affected

Consumers who have bought or used any of the products shown below.

Affected products

Product	Risk	Retail location
Dalacin T Gel 1% Anti-bacterial gel for acne	Labelled (in Japanese) to contain clindamycin	Pinky Floy Unit 1321 - 4500 Kingsway, Burnaby, BC
Kobayashi Aibon/Eyebon Eyewash Eyewash	Labelled (in Japanese) to contain aminocaproic acid	EJ Beauty 2270 - 4000 No.3 Road Richmond, BC
Sante FX Neo (black and silver packaging) Eye drops	Labelled (in English) to contain neostigmine methylsulfate and aminocaproic acid	Pinky Floy Unit 1321 - 4500 Kingsway, Burnaby, BC EJ Beauty 2270 - 4000 No.3 Road Richmond, BC
Sante FX NEO (multicolored packaging) Eye drops	Labelled (in Japanese) to contain neostigmine methylsulfate and aminocaproic acid	EJ Beauty 2270 - 4000 No.3 Road Richmond, BC
Sante FX V+ Eye drops	Labelled (in English) to contain neostigmine methylsulfate and aminocaproic acid	Pinky Floy Unit 1321 - 4500 Kingsway, Burnaby, BC
Sante PC Eye drops	Labelled (in Japanese) to contain neostigmine methylsulfate	EJ Beauty 2270 - 4000 No.3 Road Richmond, BC

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.

Clindamycin in topical format 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.

Media enquiries

Health Canada
613-957-2983
hc.media.sc@canada.ca

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

Health Canada removed the products from sale at the retail locations. The companies were also asked to stop selling them on their websites (www.floybeauty.com and www.ejbeauty.ca). Health Canada is working with the Canada Border Services Agency to help prevent the importation of these products. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians as necessary.