Lot Recall GenTeal Gel and Gel Drops

November 23, 2005 - Novartis Ophthalmics and the FDA notified healthcare professionals and patients of a voluntary recall due to a lack of sterility assurance of seven lots of two over-the-counter (OTC) 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 products 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.

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.

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.

Consumers who have purchased GenTeal® Gel or GenTeal® GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336. As always, pharmacies and members can also contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this new product warning.