Earlier this month, Texas-based Alcon Laboratories announced a voluntary recall of its Systane Free LIQUID GEL lubricant eye drops, citing possible mold contamination. According to a release posted by the U.S. Food and Drug Administration, the recall is Ã¢â‚¬Å“in response to 11 consumer reports citing the presence of foreign material.Ã¢â‚¬Â
The company said that the development of an infection is considered Ã¢â‚¬Å“unlikelyÃ¢â‚¬Â and that none of the reports included any incidents of fungal infections. Ã¢â‚¬Å“Alcon is absolutely committed to providing the highest level of quality eye care products,Ã¢â‚¬Â said Kevin Buehler, AlconÃ¢â‚¬â„¢s U.S. senior vice president and chief marketing officer. Ã¢â‚¬Å“We took this voluntary action even though it is unlikely that eye infections would occur as a result of this issue.Ã¢â‚¬Â
The recall only applies to the companyÃ¢â‚¬â„¢s Free LIQUID GEL formulation, and the company believes the issue is related to something specific about that formula and does not have anything to do with its manufacturing processes or facilities. All other Systane eye drops are still considered to be safe, and anyone who has purchased the Free LIQUID GEL product will be eligible for a replacement bottle of SystaneÃ¢â‚¬â„¢s original formulation.
The cost of the recall to the company is predicted to be in the $8-10 million range. The LIQUID GEL formulation has been on the market for just shy of one year, and the company has distributed approximately 5 million bottles of the product in the United States and Puerto Rico since its inception.