Warning

2004-70
December 23, 2004
For immediate release

Warning not to use Lot 4G03 Artificial Tears Extra

OTTAWA - Health Canada is warning consumers not to use Lot 4G03 of the product Artificial Tears Extra due to contamination with bacteria.

The product, distributed in Canada by Pharmascience Inc., is sold in 15ml plastic bottles packaged inside individual boxes. The lot number for this product can be found on the top of the box or front panel of the bottle. Sold as an over-the-counter drug to relieve eye irritation or dryness, this product is distributed across Canada.

A recall of the affected lot has been initiated by the distributor following confirmation of the presence of the bacteria Sphingomonas paucimobilis in this lot. Although no adverse reactions have been reported to Health Canada at this time, contamination with this bacteria is of particular concern for serious eye infection in people who are immune suppressed, such as those with HIV/AIDS or those undergoing chemotherapy. Such infections could result in permanent damage to the eye.

Health Canada is advising consumers who use Artificial Tears Extra to check the lot number on the bottle. If it is Lot 4G03, they should immediately stop using the product. People who experience symptoms of eye infection (such as redness, swelling, discharge, pain, itchiness, increased sensitivity to light and change in vision) while using the affected lot, should seek medical attention.

Health Canada continues to monitor the effectiveness of the recall.

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Media Inquiries:
MRO
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991