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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Novartis Ophthalmics Recalls Seven Lots of GenTeal  Products in the US

Lucia Aurello
862 778 0788

FOR IMMEDIATE RELEASE - East Hanover, NJ -- November 16, 2005 -- Novartis Ophthalmics announced today it has voluntarily recalled a total of seven lots of two products intended for use in the eye. Novartis Ophthalmics takes its mission of patient care and providing quality products very seriously, and therefore, believes it is necessary to take this precautionary action. The recalls are being conducted with the knowledge of the FDA.

Novartis Ophthalmics is recalling five lots of GenTeal® Gel, a non-prescription drug product used to relieve dryness of the eye.

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 GenTeal® Gel recall is being conducted following concerns regarding sterility of the product made for Novartis by a contract manufacturer. Additional sterility tests were conducted on several lots of GenTeal® Gel. Test results 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.

Novartis Ophthalmics is also recalling two lots of GenTeal® GelDrops. The two lots 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.

The GenTeal® GelDrops lots are being recalled due to a lack of sterility assurance. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people, and Novartis initiated the recall as a precautionary measure. The sterility assurance issues have been corrected. Only the two distributed GenTeal® GelDrops lots are affected.

Consumers who have purchased GenTeal® Gel or GenTeal® GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336.


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