Warning

2006-113
November 22, 2006
For immediate release

Health Canada warns consumers not to use the product Embrun de mer due to the risk of serious bacterial infection

OTTAWA - Heath Canada is warning Canadians not to use the unauthorized product Embrun de mer promoted for the treatment of skin irritation in newborns and adults because it contains unacceptable amounts of harmful bacteria. Newborns are especially vulnerable to adverse events associated with this product, since their immune systems are not fully developed.

The label of Embrun de mer claims that the product helps to heal wounds and is beneficial for acne, eczema, psoriasis and athlete’s foot. If this product is used on broken or otherwise sensitive skin, a serious infection may occur. Although Embrun de mer is promoted for use on the skin, it can be inhaled as it is sprayed on the face and body, which may lead to increased risk of infection.

Embrun de mer is manufactured by O de Mer Propulsion Inc. in Ste-Adèle, Quebec, and is sold in liquid form in 250 ml bottles as a “Corporal and Facial Mist.”

O de Mer Propulsion Inc. stopped the sale of Embrun de mer in July 2006 and is proceeding to recall the product. Health Canada is monitoring the effectiveness of the recall. Health Canada has received confirmation from the company that Embrun de mer is sold in health food stores and in naturopathic clinics in the province of Quebec.

Consumers who have purchased Embrun de mer should stop using it immediately and are advised to contact their health care provider if they have any concerns. To date, no adverse reactions suspected to be associated with this product have been reported to Health Canada.

Consumers requiring more information on this warning can contact the Health Canada public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
email: cadrmp@hc-sc.gc.ca

The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709