OTTAWA, ONTARIO -- (Marketwired) -- 07/06/13 -- The 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. 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 consumers should do- Do not purchase or use Veslon Aqueous Chlorhexidine Gluconate Solution.- Contact your healthcare professional with any questions or concernsregarding the use of this product.- Report any adverse reaction potentially related to these products toHealth Canada.What health professionals should do- Do not purchase or use Veslon Aqueous Chlorhexidine Gluconate Solution.- Ensure that the products you purchase have a valid eight-digit HealthCanada market authorization (DIN, NPN or DIN-HM).- A database of all authorized drug products is available on Health Canada'swebsite. A similar database for natural health products (NHPs) is alsoavailable.============================================================================
What Health Canada is doing:
Health Canada is advising Canadians regarding the sale of this unauthorized product. Health Canada has also asked Veslon Cosmetics to start a recall of the product.
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.
============================================================================Products affected:Aqueous chlorhexidine gluconate solution 2% w/v with 4% v/v isopropylalcohol (invalid DIN 704261)============================================================================
For more information:
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.
How to report problems to Health Canada:
Health Products and Food Branch Inspectorate
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