UPDATE: 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
• What you should do
• Who is affected
• What industry professionals should do
• Background
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries
• What Health Canada is doing

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

Related AWRs

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

What Health Canada is doing

Health Canada officials have been on site at Veslon Cosmetics’ manufacturing facility in order to gather information about the company’s products and distribution network, which is what led to this expanded advisory. Health Canada is also contacting all known customers.