Alcon recalling Systane Free Liquid Gel drops in U.S.

FORT WORTH, Texas — Alcon Laboratories is voluntary recalling its Systane Free Liquid Gel lubricant eye drops after 11 reports of consumers finding foreign material in the drops, the company announced.

Alcon Laboratories, a subsidiary of Alcon, is recalling only the Systane Free Liquid Gel eye drop formulation, which it distributed only in the United States and Puerto Rico. No other Systane formulations are affected, company officials noted in a press release.

Tests of particles obtained from opened, partially used bottles identified the foreign material as mold.

"However, because of the characteristics of these molds, the development of an infection is considered unlikely," the company said in the release. "In fact, Alcon has received no reports of fungal infections associated with the 11 reports. The company is taking this action to voluntarily recall Systane Free Liquid Gel because eye drops that become contaminated after opening the bottle may cause eye infections. Alcon has notified the U.S. Food and Drug Administration of this voluntary action," the release said.

Alcon has tested both returned product and retained samples from lots associated with reports of mold. It has also conducted a comprehensive review of its manufacturing records. Based on that testing and manufacturing analysis, the company determined that the problem is related to the specific formulation of Systane Free Liquid Gel and not the result of any manufacturing processes, according to the release.

"Therefore, the recall applies only to Systane Free Liquid Gel. The original formulation of Systane lubricant eye drops and Systane unit dose are not part of this recall and can continue to be used safely," the release said.

A copy of the letter from Alcon informing physicians of the recall is available on the Systane product Web site.

Annual sales of Systane Free Liquid Gel account for less than 10% of Alcon's artificial tear sales in the U.S. and Puerto Rico and less than 0.2% of Alcon's total global sales, the company said. The company has distributed more than 5 million bottles of the formulation since its introduction in January, the release said.

The company estimated that the pre-tax cost of the recall will range from $8 million to $10 million but that it should not materially affect projected sales or profits in 2007.