The U.S. Food And Drug Administrtation (FDA) is warning consumers not to purchase and to immediately stop using two dozen over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness.
These products are marketed under the following brands:
Leader (Cardinal Health)
Rugby (Cardinal Health)
The FDA recommends that consumers discard these products.
The FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.
These products are intended to be sterile. 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.
CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online, but should not be purchased.
The FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to the MedWatch Adverse Event Reporting program.
A full list of the infected eye drops is available online.
The FDA has not received any adverse event reports of eye infection associated with these products as of this current time.