Warning

2005-128
November 18, 2005
For immediate release

Health Canada warns consumers not to use certain lots of GenTeal Gel due to potential health risk

OTTAWA - Health Canada is warning consumers not to use certain lots of GenTeal Gel, 3.5mL and 10 mL, a lubricant eye gel, due to the risk of serious eye infection. There is a risk that the product may not be sterile.

A voluntary recall of the affected lots listed below has been initiated by the distributor, Novartis Pharmaceuticals Canada.

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

Health Canada is advising consumers who use GenTeal Gel to check the lot number and expiry dates on the tube. If consumers have any of the lots and associated expiry dates listed below, they should immediately stop using the product and return it.

The Drug Identification Number (DIN) for this product is 02242977. The DIN can be found on the front panel of the product label and outer packaging. There are 14 lots affected, 10 mL size sold in stores and 3.5 mL size distributed as physician samples. Lot numbers and expiry dates can be found on the bottom of the box or tube.

GenTeal Gel Sample Size 3.5 mL
Lot Exp
Z12417    Dec-05
Z13029    Apr-06
Z12906    May-06
Z12907    Jun-06
Z12908    Jun-06
Z13414    Jun-06
Z13171    Jun-06
Z13172    Jul-06
Z13173    Jul-06

GenTeal Gel Retail Size 10 mL
Lot Exp
Z12420    Dec-05
Z12902    Mar-06
Z13031    Apr-06
Z13318    Jul-06
Z13448    Nov-06

This product is used for the temporary relief of discomfort due to minor irritations of the eye and as a protectant against further eye irritation or to relieve dryness of the eye. It is sold without a prescription as an over-the-counter drug and is widely 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 compliance issues at a third party manufacturing site pertaining to good manufacturing practices. The sterility of the product cannot be fully assured.

To date, Health Canada has received no reports of adverse reactions associated with this product. To report a suspected adverse reaction, health professionals and consumers may contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by phone, toll free 1-866-234-2345, by fax 1-866-678-6789 or via email: cadrmp@hc-sc.gc.ca. Consumers can also visit Health Canada's website.

Health Canada advisories are posted at the following web address:
http://ww.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/index_e.html

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

Public Inquiries:
(613) 957-2991
1-866 225-0709