Unauthorized health products from Veslon Cosmetics and Super Discount Distributing


Starting date:
July 13, 2013

Posting date:
July 17, 2013

Type of communication:
Advisory

Subcategory:
Natural health products

Source of recall:
Health Canada

Issue:
Unauthorized products

Audience:
General Public

Identification number:
RA-34623

Issue

Following up on its previous advisory, Health Canada has identified additional unauthorized products that may have been sold by Veslon Cosmetics and/or Super Discount Distributing. These products are not authorized and may have invalid Drug Identification Numbers (DIN) on their labels.

As unauthorized products, the safety, quality and effectiveness of these products is in question Health Canada also has significant concerns about Veslon's manufacturing facility, as it has not been licensed or inspected by Health Canada for compliance with Good Manufacturing Practices and required in the Food and Drug Regulations. As a result, these products may pose a risk for patients and consumers.

Products are indicated to be used as a topical skin antiseptic, for the treatment of superficial skin infections, preparation of patients for surgery or preparing the skin for injection, for dressing wounds, burns, storage of clinical thermometers or preparation for catheterization.

Products sold by Veslon Cosmetics and/or Super Discount Distributing
Name Ingredients Labelled DIN

Veslon Isopropyl Rubbing Alcohol USP 230mL, 450mL Isopropyl Alcohol 70% 00571636

Veslon Poviodine Detergent 450mL Povidone / Iodine 7.5% 571644

Veslon Isohogel 220mL Isopropyl Alcohol 70% 571652

Veslon Poviodine Solution 120mL Povidone / Iodine 10% 571660

Veslon Aqueous Chlorhexidine Gluconate Solution 450mL Chlorhexidine Gluconate 2%, Isopropyl Alcohol 4% 704261

Veslon Aqueous Solution (1:100) 230mL, 450mL Chlorhexidine 0.015%,
Cetrimide 0.15% 01914472

Veslon Aqueous Solution (1:200) 450mL Chlorhexidine 0.0075%,
Cetrimonium Bromide 0.075% 01941445

Veslon Sterilon Towelette Chlorhexidine 0.5% 704261

Veslon Isopropyl Alcohol Towelette Isopropyl Alcohol 70% 571636

Veslon Sterilon Hand Disinfecting Waterless Gel 450mL Chlorhexidine 0.5%,

Isopropyl Alcohol 70% 704261


What you should do

Do not purchase or use drugs or natural health products (NHPs) sold by Veslon Cosmetics and/or Super Discount Distributing.

Contact your healthcare professional with any questions or concerns regarding the use of these products.

Report any adverse reaction potentially related to Health Canada.

Who is affected

Any consumers or health care facilities that may have purchased products manufactured or packaged by Veslon Cosmetics and/or Super Discount Distributing. At this time, it appears most of the distribution of these unauthorized products is limited to facilities in Ontario, such as hospitals, and health care clinics. However, distribution outside of Ontario is possible. The distribution of unauthorized products may have also occurred to a small number of pharmacies.


What industry professionals should do

Do not purchase or use any of the products sold by Veslon Cosmetics and/or Super Discount Distributing.

Contact Health Canada if you have purchased any products from Veslon Cosmetics and/or Super Discount Distributing to assist Health Canada in tracking the distribution of these unauthorized products

Ensure that the products you purchased have a valid eight-digit Health Canada market authorization (DIN, NPN or DIN-HM).

Consult the publicly available database of all authorized drug products, available on the Health Canada website. A similar database for natural heath products (NHPs) is also available.

Background

Veslon Cosmetics has no active product licences in Canada, and does not have the necessary licences to manufacture or package drugs or NHPs.

The majority of the products identified by Health Canada as potentially having been sold by Veslon Cosmetics are antiseptic solutions and gels, and similar products.

Given the lack of clarity in the company’s records as to what products were sold, and when, Health Canada is advising about all products that may have been sold by the company.
Report health or safety concerns

Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Tel: 1-800-267-9675
Fax: 613-946-5636


Previous Advisory on this Issue:

Starting date:
July 6, 2013

Type of communication:
Advisory

Subcategory:
Drugs

Source of recall:
Health Canada

Identification number:
RA-34487

Issue

An unauthorized product used as a topical skin antiseptic is being sold by Veslon Cosmetics and Super Discount Distributing. The product, Veslon Aqueous Chlorhexidine Gluconate Solution 2% w/v with 4% v/v isopropyl alcohol, is unlicensed and has an invalid Drug Identification Number on its label. Since the product has not been authorized by Health Canada, its safety, quality and effectiveness are unknown, and it may pose a risk when used for the treatment of superficial skin infections, preparation of patients for surgery or preparing the skin for injection.


Products affected

Aqueous chlorhexidine gluconate solution 2% w/v with 4% v/v isopropyl alcohol (invalid DIN 704261)
What you should do

Do not purchase or use Veslon Aqueous Chlorhexidine Gluconate Solution.

Contact your healthcare professional with any questions or concerns regarding the use of this product.

Report any adverse reaction potentially related to these products to Health Canada.

Who is affected

Consumers or health care facilities that have purchased or used this product for the treatment of superficial skin infections, to prepare patients for surgery or to prepare the skin for injection.

What industry professionals should do

Do not purchase or use Veslon Aqueous Chlorhexidine Gluconate Solution.
Ensure that the products you purchase have a valid eight-digit Health Canada market authorization (DIN, NPN or DIN-HM).

A database of all authorized drug products is available on Health Canada's website. A similar database for natural health products (NHPs) is also available.

Background

The label of Veslon Aqueous Chlorhexidine Gluconate Solution 2% w/v with 4% v/v isopropyl alcohol lists a 6-digit Drug Identification Number (DIN) that is not valid. Veslon Cosmetics has no active product licences in Canada, and does not have the necessary licences to manufacture drugs or NHPs.