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Archived – Health Canada warns against using Blue Cap Shampoo and Spray

Starting date: November 20, 2004 Posting date: November 20, 2004 Type of communication: Advisory Subcategory: Household Items Source of recall: Health Canada Issue: Undeclared Substance, Product Safety Audience: General Public Identification number: RA-11000243

Health Canada is warning consumers not to use Blue Cap Shampoo and Blue Cap Spray due to the presence of Betamethasone-21-propionate, a topical corticosteroid (steroid), found in the shampoo and the potential of a similar substance found in the spray, neither of which are declared on the labels. Blue Cap products have not been approved for sale in Canada.

Betamethasone-21-propionate may be obtained only by prescription. Use of Betamethasone-21-propionate should be monitored by a physician. Corticosteroids, such as Betamethasone-21-propionate, applied to the skin can cause thinning of the skin that can lead to permanent scarring, secondary infections, signs of Cushing's syndrome, hyperglycaemia, and glucosuria.

Blue Cap Shampoo and Blue Cap Spray are manufactured by Catalysis in Spain and distributed by Catalysis Products of Canada. Promotional material available on the Internet indicated that Blue Cap Shampoo treats dandruff and seborrhea. The shampoo is packaged in 150 mL bottles. Blue Cap Spray is promoted for daily hygiene for individuals who may be affected by different types of skin conditions such as psoriasis, seborrheic dermatitis and eczema. The spray is packaged in 100 mL aerosol containers.

Information available to Health Canada indicates that consumers may have purchased Blue Cap products over the Internet, but that the products were not widely available through traditional retail sources. The Canadian distributor has removed all Blue Cap products from the Canadian market following confirmation of the undeclared presence of the corticosteroid (betamethasone-21-propionate) in the Blue Cap Shampoo. In addition, the website that was previously selling Blue Cap products is no longer operating. Health Canada has issued an alert at customs for Catalysis Products of Canada to ensure that Blue Cap products are not imported into Canada by this company.

Health Canada is recommending that individuals using Blue Cap products contact their physician. Consumers who have been using Blue Cap products or other topical corticosteroids for several months should not abruptly cease use without consulting their physician as there is a low risk that individuals may not be able to produce steroids which are released naturally in the body. This may lead to a potentially serious or life-threatening hormone deficiency.

Health Canada encourages consumers to use only drug products which have been issued an eight-digit Drug Identification Number ( DINs ) or a Natural Product Number ( NPN , or DIN-HM for homeopathic medicines) which allows consumers to distinguish between approved and unapproved drugs. Before a drug can be sold in Canada, the manufacturer must first provide

Health Canada with scientific evidence that the drug is safe and effective at meeting its stated claims of treatment.

Health Canada has received one complaint associated with the use of these products and the department is taking steps to confirm that the product has been removed from the Canadian market.



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