The FDA issued a notice warning consumers about 26 over-the-counter eye drop products that could result in eye infections.
In its notice, the FDA instructed consumers not to purchase and to immediately stop using these products. Using those eye drops could lead to the risk of infections that could result in partial vision loss or blindness.
Products included in this warning are marketed under brands such as CVS Health and Cardinal Health’s Leader and Rugby. Rite Aid, Target Up&Up and Velocity Pharma also market affected eye drop products.
According to the FDA, the products are intended to be sterile. However, ophthalmic drug products pose a potential heightened risk of harm to users. Drugs applied to the eyes bypass some of the body’s natural defenses.
The FDA recommended the manufacturer of the products recall all lots on Oct. 25, 2023. Its recommendation came after agency investigators found insanitary conditions in the manufacturing facility. The agency also collected positive bacterial tests from environmental sampling of critical drug production areas in the facility. FDA also recommends that users properly discard the products.
CVS, Rite Aid and Target intend to remove the products from their store shelves and websites. Leader, Rugby and Velocity brands may still be available to purchase in stores and online. The FDA says consumers should not purchase those brands.
No reports of adverse events related to eye infections associated with these products have made their way to the FDA, the agency said.
