Novartis voluntarily recalls GenTeal products

East Hanover, NJ-Novartis Ophthalmics has recalled seven lots of two GenTeal products in the United States, and 15 lots of two GenTeal products in Canada, over concerns that the dry-eye products might not be sterile.

The voluntary recalls, initiated last year with knowledge of the FDA and Health Canada, involve GenTeal Gel, in retail and physician sample sizes, and GenTeal GelDrops, as well as one lot of GenTeal Artificial Tears distributed in Canada.

The GenTeal Gel lots were made by an unnamed contract manufacturer. The company said tests on the U.S.-distributed lots indicated the presence of mold in a small number of samples, leading to the recall. About 142,500 tubes in the five affected lots were distributed nationwide from March to November 2004.

Two lots of GelDrops, approximately 12,000 dropper bottles distributed in the United States in October, were recalled as a precaution because of a lack of sterility assurance, the company said. "While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people," Novartis announced.

The GenTeal Artificial Tears recall involved one lot with an expiration date of 2008-08. The product was made by CIBA Vision Canada Inc., Sterile Manufacturing, and passed sterility tests before its sale. However, the company said, the recall is a precautionary measure based on a recent review of production facility controls.

A spokeswoman for CIBA Vision, the eye care unit of Novartis, was not available for comment.

For more information on the recalls, call Novartis Ophthalmics at 866/393-6336.