WEDNESDAY, Nov. 23 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday a voluntary recall of seven lots of two products, GenTeal Gel and GenTeal GelDrops, due to a lack of sterility assurance. Both are non-prescription eyedrops meant to relieve dryness of the eye.
Test results on GenTeal Gel showed mold contamination in a small number of samples. Five lots of GelTeal Gel were recalled, including 142,500 tubes distributed nationwide from March to November 2004, and two lots of GenTeal GelDrops, including about 12,000 dropper bottles distributed in October 2005.
"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," according to the FDA.
Novartis Ophthalmics said the company issued the recall as a precautionary measure. "The sterility assurance issues have been corrected," the company said in a statement. "Only the two distributed GenTeal GelDrops lots are affected."
More Information -- FDA
More Information -- Novartis
