• Posted October 30, 2023

FDA Warns Eyedrops From Major Brands May Cause Infection

Federal regulators are warning consumers to stop using eyedrops and gels from several major brands after finding unsanitary conditions in a manufacturing plant.

Twenty-six eye care products are part of the alert. Contaminated products have the potential to cause eye infection and blindness because drugs applied to the eye can bypass some of the body's defenses.

Those concerning the U.S. Food and Drug Administration are branded CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up and Velocity Pharma.

The FDA urged the manufacturer to recall all lots of these products. CVS, Rite Aid and Target are pulling products from shelves and websites.

Although there were no reports of infection, bacterial tests were positive in critical drug product areas of the plant.

The FDA's list of eye products to avoid is here.

Patients and providers should report any issues to the FDA.

Consumers should discard products involved in the recall at a drug take-back site. They can also check the FDA's flush list to see if they can be safely discarded at home, the New York Times reported.

Certain products -- those branded Leader, Rugby and Velocity -- may still be available for purchase in stores and online. Don't buy them, the FDA advised.

Rite Aid is removing “applicable Rite Aid branded products” from store shelves, a spokeswoman said.

CVS “immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio,” a spokeswoman said, adding that customers could return those products for a full refund.

These are not the first in recent reports of unsanitary conditions at facilities making eye care products.

EzriCare Artificial Tears and Delsam Pharma Artificial Tears were linked to a drug-resistant strain of the bacterium Pseudomonas aeruginosa, leading the FDA and U.S. Centers for Disease Control and Prevention to warn consumers to stop using them in January. That situation was linked to at least four deaths and vision loss in 14 patients.

Then in March, Canadian drug company Apotex recalled prescription eyedrops after some developed cracks in the bottle caps.

More information

The U.S. Centers for Disease Control and Prevention has more on the earlier cases of eye infections associated with eyedrops.

SOURCES: U.S. Food and Drug Administration; New York Times