Stop using 26 eye drops from CVS, Rite Aid, Target, and others, FDA warns

No infections yet linked, but FDA found contamination in manufacturing facility.

The Food and Drug Administration is warning consumers to ditch 26 over-the-counter eye drop products found at big retailers—including CVS, Rite Aid, and Target—due to a risk of infection. Consumers should not buy any of the products and should immediately stop using them if they've already purchased them.

The products include Target's branded Up&Up Dry Eye Relief Lubricant Eye Drops and Up&Up Extreme Relief Dry Eye, as well as Lubricant Eye Drops and Lubricant Gel Drops branded by CVS Health and Rite Aid. The warning also includes eye drop products branded as Rugby and Leader (both from Cardinal Health) and Velocity Pharma. A full list can be found here, as can links to report adverse events.

In an adversary posted Friday, the FDA reported that no infections or adverse events have been linked to the products so far. But the agency said it "found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility."

The potential for contamination is particularly concerning for products intended for the eye because the eye is considered an immune privileged site of the body. That is, innate immune responses are held back in specific locations of the body to prevent damage from inflammation—damage that, in the case of the eye, could lead to vision loss.

If pathogens from contaminated eye drops are applied directly to the eye, the resulting infection could also lead to vision loss and even blindness, the FDA warns.

On October 25, the FDA recommended that the manufacturer of the products issue a recall of all lots. The FDA noted that CVS, Rite Aid, and Target are in the process of pulling the drops, but products branded from Leader, Rugby, and Velocity may still be available for purchase online or on shelves.

The sweeping warning and recommendation for a recall of 26 products comes amid a string of eye drop contamination problems this year. Most notably, an outbreak of extremely drug-resistant bacterial infections linked to EzriCare Artificial Tears came to light at the beginning of the year. At the latest count, 81 people in 18 states were infected. Four people died in connection with the outbreak, four others required having one of their eyeballs surgically removed, and 14 other people lost vision. In March, the FDA warned of two other eye drop products, from Pharmedica and Apotex, which were not linked to the outbreak but raised concerns regarding non-sterility.

Source