Novartis Ophthalmics is recalling five lots of GenTeal gel, a non-prescription drug product used to relieve dryness of the eye. The five lots include about 142,500 tubes that were distributed in the US from March to November 2004. The company says that GenTeal gel is made for Novartis by a contract manufacturer.
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 that include about 12,000 dropper bottles that were distributed across the US 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.
“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,” said the company in a statement.