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U.S. Department of Health and Human Services

Safety

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GenTeal Gel and GenTeal GelDrops

Audience: Ophthalmologists, other healthcare professionals and consumers

[Posted 11/22/2005] Novartis Ophthalmics and FDA notified healthcare professionals and patients of a voluntary recall due to a lack of sterility assurance of seven lots of two products, GenTeal Gel and GenTeal GelDrops, intended for use to relieve dryness of the eye. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people.

The five lots of GenTeal Gel include about 142,500 tubes that were distributed nationwide from March to November 2004.

The two lots of GenTeal GelDrops include about 12,000 dropper bottles that were distributed nationwide in October 2005.

Test results for GenTeal Gel indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.

[November 16, 2005 - Press Release - Novartis]