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Archive – Health Canada Warns Consumers Not to Use a Certain Lot of Aquify 2-mL Long-Lasting Comfort Drops Due to Potential Health Risk

Starting date:
November 18, 2005
Posting date:
November 18, 2005
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information, Contamination
Audience:
General Public
Identification number:
RA-11000427

Health Canada is warning consumers not to use Lot 52234 of the product Aquify 2-mL Long-Lasting Comfort Drops due to possible contamination with bacteria that may cause serious eye infection. A recall of the 3,024 units affected has been initiated by the manufacturer, CIBA Vision Canada Inc., Sterile Manufacturing.

People who are immune suppressed, such as those with HIV/AIDS, or who are undergoing chemotherapy or taking drugs that cause immune suppression, may be at a higher risk for infection.

The product is used to relieve eye irritation or dryness and help make wearing contact lenses more comfortable. It has been distributed as free samples to patients by eye-care practitioners. According to the company, the product was tested prior to release for distribution and met all specifications, including sterility. However, the company advised Health Canada that it is recalling the product as a precautionary measure based on a recent review of the production facility controls.

People who used the affected lot and experience symptoms of eye infection such as redness, swelling, discharge, pain, itchiness, increased sensitivity to light and change in vision should seek medical attention.

Health Canada is advising consumers who received Aquify 2-mL Long-Lasting Comfort Drops to check the lot number on the bottle. Lot numbers can usually be found on the top of the box or front panel of the bottle. In the case of product from Lot 52234, with an expiry date of 2007-08, consumers should immediately stop using the product and return it where it was received.

Health Canada has not received complaints associated with the use of this product and continues to monitor the effectiveness of the recall.

Health Canada advisories are posted at the following web address:
Advisories, Warnings and Recalls - 2005

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