Results RNA said this week that it voluntarily recalled its Lubrisine eye drops following an FDA inspection that found the product was not manufactured with sterile practices.
The company also said that the eye drops, which are designed to lubricate dry eyes, were found to contain undeclared colloidal silver. Exposure to colloidal silver over an extended period of time could permanently discolor the conjunctiva, Results RNA warned.
The company has not received any reports of adverse events related to the eye drops and no illnesses have been reported to date. The recall affects all lots of Lubrisine eye drops manufactured starting May 12, 2012.
Results RNA said it notified its distributors and customers of the recall via email on Dec. 14, providing directions for returning all units of Lubrisine eye drops.
“Consumers with Lubrisine Eye Drops should stop using the product immediately,” the company wrote in a notice published by the FDA.