Health Canada seized three unauthorized eye drop products from Floy Beauty stores in Toronto, Ontario, because they may pose serious health risks

Starting date:
December 20, 2019
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information, Unauthorized products
Audience:
General Public
Identification number:
RA-71943

Last updated:

OTTAWA – Health Canada is advising consumers that it has seized three unauthorized eye drop products from two Floy Beauty stores in Toronto, Ontario, because they may pose serious health risks. The seized products are Santen Sante FX Neo, Santen Sante FX V+, and Santen Sante Antibacterial Eye Drops.

According to the product labels, these 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 conditions and may cause serious side effects.

Selling unauthorized health products in Canada is illegal. Health products that have not been authorized by Health Canada have not been assessed for safety, effectiveness and quality, and may pose serious health risks. For example, unauthorized health products may be contaminated, may contain dangerous ingredients not listed on the label, or may not contain the ingredients shown on the label.

Who is affected

Consumers who have bought or are using the affected products.

Affected products

Photo Product Risk Retail Location
Santen Sante FX Neo

Santen Sante FX Neo

Labelled to contain neostigmine methylsulfate and aminocaproic acid

Floy Beauty
5 Northtown Way
Toronto, ON

Floy Beauty
4750 Yonge Street, Unit 147
North York, ON

Santen Sante FX V+

Santen Sante FX V+

Labelled to contain neostigmine methylsulfate and aminocaproic acid

Floy Beauty
5 Northtown Way
Toronto, ON

Floy Beauty
4750 Yonge Street, Unit 147
North York, ON

Santen Sante Antibacterial Eye Drops Santen Sante Antibacterial Eye Drops Labelled to contain sulfamethoxazole

Floy Beauty
5 Northtown Way
Toronto, ON

Floy Beauty
4750 Yonge Street, Unit 147
North York, ON

What consumers should do

  • Stop using these products. Consult your healthcare 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.

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.

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.

Sulfamethoxazole: This is a prescription sulfa-containing antibiotic drug, normally taken by mouth to treat bacterial infections in the bladder, lungs and gastrointestinal tract. There are no eye drops containing sulfamethoxazole authorized by Health Canada. When taken by mouth, rare side effects can include death due to severe blistering skin reactions (Stevens-Johnson Syndrome and toxic epidermal necrolysis), liver failure, kidney failure, failure to produce blood cells, and allergic reactions in the lungs. Common side effects may include nausea and vomiting, diarrhea, headache, rash, fatigue, nosebleeds, hair loss and thrush. Sulfa-containing drugs should not be used in women who are pregnant or breastfeeding and in infants under two months of age.

Media enquiries

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

Public enquiries

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

Images

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