The Food and Drug Administration is warning U.S. consumers not to use certain over-the-counter eye drops, as more than two dozen eye products from several major brands carry risk of infection.
“These products are intended to be sterile,” regulators said Friday. “Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.”
As of Monday, no injuries have been reported; but federal regulators have urged consumers to immediately cease using any eye drop products from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma.
The recall is associated with an FDA finding of “insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.”
A Northeastern drug expert says that unlike prescription products, which undergo “more rigorous” quality control, over-the-counter medications — once approved by the FDA — aren’t subject to testing and quality control measures as stringent as their doctor-ordered counterparts.
“The challenge with a lot of the [over-the-counter] product is unfortunately we’re not seeing as rigorous a testing paradigm once the product has been approved for use and is widely available,” says Mansoor Amiji, university distinguished professor of pharmaceutical sciences and chemical engineering at Northeastern.