FDA warns against purchasing eye drops manufactured in ‘unsanitary conditions’

The Food and Drug Administration on Monday expanded its warning not to buy or use eye drops sold by several major retailers, sometimes under their own brands.

The warning now includes the product Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart, the FDA said. “Walmart is removing the product from its store shelves and website,” it said in an updated drug safety warning.

A list of eye drops released under the FDA warning also includes those sold under the brand names CVS Health, Leader, Rugby, Rite Aid, Target Up & Up and Velocity Pharma.

The agency said retailers should remove them from shelves and consumers should throw them away. In addition to Walmart’s noted cooperation, the FDA said CVS, Target and Rite Aid were removing the eye drops from shelves and making them unavailable on their websites.

The FDA said infection and vision loss were possible, although it had not received any reports of either. The alarm was raised after inspectors discovered contamination in the production area.

“The FDA recommended the manufacturer of these products to recall all lots on October 25, 2023, after agency investigators found unsanitary conditions at the manufacturing plant and positive bacterial test results from a environmental sampling of critical drug production areas of the facility,” she said in her warning. .

The agency did not name the manufacturer or the location of the facility. He said he recommended last week that the manufacturer recall the products, but it’s unclear whether he responded or complied.

Retailer CVS and pharmaceutical company Cardinal Health, makers of eye drops sold under the Leader and Rugby brands, both said separately that Velocity Pharma LLC was the supplier.

Velocity Pharma is based in Farmingdale, New York. It did not respond to several inquiries, including a question about where its eye drops are made.

The FDA did not respond to an inquiry about the location of the facility that it said was the site of unsanitary conditions.

CVS said in a statement that it stopped selling the eye drops as soon as it received the FDA warning. “Customers who purchased these products may return them to CVS Pharmacy for a full refund,” the release said.

Cardinal Health said: “We are working with Velocity Pharma and the FDA to initiate a recall of all affected Rugby Laboratories and Cardinal Health Leader brand eye drop products. »

Walmart and Target did not immediately respond to requests for comment.

The Centers for Disease Control and Prevention said earlier this year that 81 people in 18 states had tested positive for the bacteria. Pseudomonas aeruginosawhich is resistant to most antibiotics.

CDC and FDA officials said most of the cases may be linked to eye drops made in India and sold under the brands EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma Artificial Eye Ointment, all of which have since been recalled.

Fourteen of the 81 people were blind; four others had to remove at least one eye, officials said. Four people ultimately died, they said.

The bacteria found at the facility that caused the latest warning has not been identified.