Warning

2005-90
August 11, 2005
For immediate release

Health Canada warns consumers not to use Sweet-Ease pacifier dip

OTTAWA - 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 (See Photo attached).

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@hc-sc.gc.ca

Or visit our website: http://www.hc-sc.gc.ca/dhp-mps/medeff/advers-react-neg/index_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.

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Media Inquiries:
Christopher Williams
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

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Photographs of product