OTTAWA – Health Canada is warning consumers not to use Lot 51436 of the product Genteal Artificial Tears 25 ml due to possible contamination with bacteria. A recall of the affected lot has been initiated by the distributor, Novartis.
Use of eye drops contaminated with bacteria may cause serious eye infection. People who are immune suppressed, such as those with HIV/AIDS, or who are undergoing chemotherapy or taking drugs which cause immune suppression may be at a higher risk for infection.
The product, with an expiry date of 2008-08, is fabricated by CIBA Vision Canada Inc., Sterile Manufacturing.
Lot numbers can usually be found on the top of the box or front panel of the bottle. The Drug Identification Number (DIN) for this product is 02231289. The DIN can be found on the front panel of the product label and outer packaging.
This product is used to relieve eye irritation or dryness and is sold without a prescription as an over-the-counter drug. It is widely available and is distributed across Canada. According to the company, the product was tested prior to release for sale 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.
Health Canada is advising consumers who use Genteal Artificial Tears to check the lot number on the bottle. If it is Lot 51436, with an expiry date of 2008-08, they should immediately stop using the product and return it where it was purchased. People using the affected lot who 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 will update this advisory as soon as additional information is available. Health Canada advisories are posted at the following web address: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/index_e.html