Novartis Ophthalmics Recalls Certain GenTeal Products(Jan06)

Novartis Ophthalmics Recalls Certain GenTeal Products(Jan06)



Novartis Ophthalmics is recalling certain lots of two non-prescription products used to treat dry eye: GenTeal Gel and GenTeal GelDrops. Test results on a small number of samples of GenTeal Gel lots indicated the presence of a mold that could cause eye infections in susceptible people, particularly those with compromised immune systems. The two lots of GenTeal GelDrops are being recalled because they may not be sterile. While the risk of potential contamination for these drops is believed to be very low, the concern again is that the product could cause infections in susceptible people. The five lots of GenTeal Gel being recalled are: Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004. The two lots of GenTeal GelDrops being recalled are: Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005. Consumers who have purchased GenTeal Gel or GenTeal GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336.