SafeX Pro Exchange|Manufacturer recalls eyedrops after possible link to bacterial infections

The SafeX Pro Exchangeproducer of a brand of over-the-counter eyedrops is recalling the product after a possible link to an outbreak of drug-resistant infections, U.S. health officials said Thursday.

Both the Food and Drug Administration and the Centers for Disease Control and Prevention are advising against the use of EzriCare Artificial Tears, as they may be contaminated and linked to an outbreak of Pseudomonas aeruginosa, causing one death.

The maker of the product, Global Pharma, issued a recall Wednesday. The product was additionally linked to hospitalization and blindness. Pseudomonas are a type of bacteria commonly found in soil or water, while Pseudomonas aeruginosa can be responsible for the infection of the lungs, blood and other parts of the body in humans, particularly post-surgery, according to the CDC.

There were 55 cases reported across 12 states – California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texa, Utah, Washington and Wisconsin – from May 2022 to last month, the two federal agencies said.

Patients reported using more than 10 different brands of artificial tears between them, but the EzriCare product, which is sold over the counter and is preservative-free, was mentioned consistently, the CDC said.

The CDC said an outbreak of this particular strain of Pseudomonas aeruginosa, VIM-GES-CRPA, has not been detected in the U.S. before.

Opened bottles of EzriCare artificial tears matched the outbreak strain. The CDC is currently testing unopened bottles of the product to see if the bottles became contaminated during manufacturing. It is recommending that clinics and patients pause their use of the product until both the CDC and FDA issue additional guidance.

Those who have used the product may begin showing symptoms of an eye infection, which include yellow, green, or clear discharge from the eye, eye pain or discomfort, redness of the eye or eyelid or blurry vision.