Warning - Health Canada warns consumers not to use Sweet-Ease

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Health Canada

http://www.newswire.ca/en/releases/archive/August2005/11/c9398.html

Attention News/Health Editors:

Warning - Health Canada warns consumers not to use Sweet-Ease

pacifier dip

OTTAWA, Aug. 11 /CNW Telbec/ - Health Canada is warning

consumers across

Canada not to use Sweet-Ease, a sugar-solution pacifier dip because

one lot of

this product may contain mold. This product is used in hospitals to

soothe

babies and is not sold in stores, however some product may have been

given to

parents to take home. Health Canada is working with the distributor

of

Sweet-Ease to recall the product. Health Canada has not authorized

this

product for sale in Canada.

Sweet-Ease is marketed by Children's Medical Ventures and is

distributed

in Canada by McArthur Medical Sales. It is packaged in small

plastic,

coffee-creamer type containers (11 ml), with the brand name Sweet-

Ease, and

company name Children's Medical Ventures on the top label. The

affected lot,

distributed after June 6, 2005, is marked 2005/11/12-1N on the lid of

individual cups.

The mold, Cladosporium herbarum, in this product poses a

particular

health risk because as a contaminant on the pacifier, the infant's

mouth would

be exposed to it, and it is a parasite causing fungal infections of

the skin,

soft tissues or nails and has been documented in cases of

candidiasis and

other systemic infections, to which new-born infants and those in

intensive

care units may be particularly susceptible. Although less likely to

happen

because of this product, Cladosporium mold spores are commonly

present in both

indoor and outdoor air and when inhaled they may cause typical

allergy

symptoms of runny nose, itchy eyes, sinusitis, or asthma. Acute

respiratory

symptoms include fluid accumulation and bronchial spasms.

Canadians should only use medicinal products that have been

authorized

for sale by Health Canada. Authorized health products will either

bear an

eight-digit Drug Identification Number (DIN), a Natural Product

Number (NPN)

or a Homeopathic Medicine Number (DIN-HM). This authorization

indicates that

the product has been assessed by Health Canada for safety, efficacy

and

quality.

Parents who have used this product should consult their doctor.

Health

Canada has asked the distributor to issue a notice to hospitals

asking them to

notify their patients about this situation. Health Canada has not

received any

reports of adverse reactions associated with this product.

To report a suspected adverse reaction, please contact the

Canadian

Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada:

CADRMP

Marketed Health Products Directorate

Health Protection Building, Tunney's Pasture, AL 0701C

Ottawa, Ontario

K1A 0K9

Email: cadrmp@...

Or visit our website:

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_e.html

Health professionals and consumers may report adverse reactions

toll free

to Health Canada at:

Tel: 866 234-2345

Fax: 866 678-6789

Your call will be directed to the appropriate Regional Centre.

For further information: Media Inquiries: ,

Health

Canada, (613) 946-4250; Public Inquiries: (613) 957-2991; Health

Canada news

releases are available on the Internet at http://media.health-

canada.net