Archived - Baby Balm “Eucalyptus and Scotch Pine”

Starting date:

April 11, 2008

Posting date:

April 11, 2008

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Microbial Hazard, Product Safety

Audience:

General Public

Identification number:

RA-12000690

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

French Health Products Safety Agency

Product names

Baby Balm "Eucalyptus and Scotch Pine"

Manufacturer / Place of origin

The manufacturer and place of origin is unknown for all three products.

Product description

Euphia Natural Baby Care Baby Balm "Eucalyptus and Scotch Pine" is marketed for use on infants.

Reason for warning

The French Health Products Safety Agency recalled three lots (# 070620, expires 06/10; # 070823, expires 08/2010; and # 071114, expires 11/2010) of Baby Balm "Eucalyptus and Scotch Pine" manufactured by Euphia Natural Baby Care, because the lots exceeded the permissible limits for microbial (bacterial) contamination in France. These lots also exceed the permissible microbial (bacterial) limits in Canada. The specific microbe (bacterium) found in the products was Pseudomonas aeruginosa. Certain individuals, particularly children, may be at an increased risk of serious adverse health effects related to microbial (bacterial) contamination.

Possible side effects

Excessive exposure to certain microbes (bacteria), including Pseudomonas aeruginosa, may cause infection in immune-compromised or otherwise susceptible individuals, including children with cystic fibrosis, burns, bone-marrow transplants, or those receiving cancer treatment or broad-spectrum antibiotics. Infections may occur in the urinary tract system, the respiratory system the digestive system, the skin, the soft tissues, the bones, the joints and the blood. If the microbe (bacteria) is present in the blood, it may cause a generalised infection, in children with immune-deficiency. However, it is important to note that serious infections have also been reported in previously healthy children, particularly those younger than one year of age, some with fatal outcomes.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

Images

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