Federal health officials are advising consumers to stop using more than two dozen over-the-counter eye drops because of the risk of eye infection that can lead to partial vision loss or blindness.
The Food and Drug Administration issued an alert Friday reporting 26 eye care products, including eye drops and gels, from CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target up&up and Velocity Pharma.
The federal agency on Wednesday recommended that the manufacturer recall all batches of these products after agency investigators found unsanitary conditions at a manufacturing facility, according to an FDA news release. Bacteria tests from critical drug production areas at the facility came back positive. The agency did not immediately identify itself.
The FDA said it has not received any reports of infections associated with these products, but it encourages healthcare professionals and patients to report any cases to the agency.
According to regulators, it is essential that these products be sterile because medications applied to the eyes bypass some of the body’s natural defenses.
The FDA said consumers should properly dispose of these products by taking them to a drug take-back location or checking to see if a product is on the FDA’s “flush list” of drugs that can be safely disposed of at home.
CVS, Rite Aid and Target are removing the products from their stores and websites, the agency said. Products branded as “Leader,” “Rugby” and “Velocity” may still be available in stores and online and should not be purchased, federal regulators said.
Rite Aid confirmed through a spokeswoman that “appropriate Rite Aid branded products” would be removed from store shelves. A CVS spokeswoman said the retail chain “immediately stopped selling all Velocity Pharma-supplied products in the CVS Health Brand Eye Products portfolio in-store and online” and that customers could return those products for a full refund. The other retailers did not immediately respond to requests for comment.
There have been additional reports of problems with eye products recently.
In January, the Centers for Disease Control and Prevention and the FDA warned consumers to stop using EzriCare’s artificial tears and Delsam Pharma’s artificial tears. The eye drops have been linked to a drug-resistant strain of the bacteria Pseudomonas aeruginosa, which has been linked to at least four deaths and vision loss in 14 patients.
Apotex, a Canadian pharmaceutical company, recalled prescription eye drops in March after some bottle caps had cracks that could compromise the product’s sterility.
Experts say eye drops are generally safe to use. According to Statista, a market research firm, 123 million Americans are expected to use eye drops by 2024.