PediaCol drops Recalled By Euro-Pharm International Canada Inc

OTTAWA - Health Canada is warning parents and caregivers not to use a certain lot of PediaCol drops, a product for infants taken orally to relieve symptoms of excess gas associated with colic. The product, labelled with the lot number PDC701, was found to be contaminated with yeast and may pose serious health risks. Due to their immature immune systems, infants and young children may be at risk of adverse health effects. Children with weakened immune systems are particularly vulnerable to the potential health risks.

In general, symptoms of exposure to products contaminated with yeast may include, but are not limited to, nausea, vomiting, diarrhea, fever, weight loss, lethargy, coughing, or decreased appetite. For children with weakened immune systems the effects may be more serious.

Euro-Pharm International Canada Inc. has initiated a recall of the product. The Drug Identification Number (DIN) is 02245510 and the affected lot number of the product is PDC701, both of which and can be found on the product label. PediaCol is available at pharmacies across Canada, and over the Internet. Health Canada will monitor the effectiveness of this recall.

Health Canada advises retailers to remove the affected lot of PediaCol from their shelves, and consumers should return the product to the place of purchase. As a precautionary measure, consumers should also discard any bottles that may have been used to store or administer the product. Parents and caregivers who have administered the product to an infant and have health concerns should consult with a health care professional.

This warning may be updated if necessary as further information becomes available. Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction to this health product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

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

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

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

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