Advisory - Multiple unauthorized eye solutions and an acne gel sold at two stores in the Lower Mainland of BC may pose serious health risks
OTTAWA, April 15, 2019 /CNW/ - 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.
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%
Labelled (in Japanese)
Pinky Floy
to contain clindamycin
Anti-bacterial gel
for acne
Unit 1321 - 4500
Kingsway,
Burnaby, BC
---
Kobayashi Aibon/
Eyebon
Labelled (in Japanese)
EJ Beauty
Eyewash to contain aminocaproic
acid 2270 -4000 No.3 Road
Eyewash
Richmond, BC
---
Sante FX Neo (black
and
Labelled (in English) to
Pinky Floy
silver packaging) contain neostigmine
methylsulfate and
Unit 1321 - 4500 K
Eye drops aminocaproic acid ingsway,
Burnaby, BC
EJ Beauty
2270 -4000 No.3 Road
Richmond, BC
---
Sante FX NEO
Labelled (in Japanese)
EJ Beauty
(multicolored
packaging) to contain neostigmine
methylsulfate and 2270 -4000 No.3 Road
Eye drops aminocaproic acid
Richmond, BC
---
Sante FX V+
Labelled (in English) to
Pinky Floy
contain neostigmine
Eye drops methylsulfate and
Unit 1321 - 4500
aminocaproic acid Kingsway,
Burnaby, BC
---
Sante PC
Labelled (in Japanese)
EJ Beauty
to contain neostigmine
Eye drops methylsulfate 2270 -4000 No.3 Road
Richmond, BC
---
What consumers 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.
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.
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.
Également disponible en français
SOURCE Health Canada
