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FDA warns against buying, using eyedrops made in ‘insanitary conditions’

The Food and Drug Administration said that there have been no reports of infection or vision loss but that bacteria were found in tests at “critical” areas.
/ Source: TODAY

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

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 their store shelves and website,” it said in an updated drug safety warning.

list of eyedrops published under the FDA’s warning also includes those sold under the brands CVS Health, Leader, Rugby, Rite Aid, Target Up & Up and Velocity Pharma.

The agency said retailers should pull them from shelves and consumers should discard them. Besides Walmart’s noted cooperation, the FDA said CVS, Target and Rite Aid were pulling the eyedrops from shelves and making them unavailable on their websites.

The FDA said infection and vision loss were possible, although it has not received reports of either. It sounded alarms after inspectors found contamination in the production area.

“FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility,” it said in its warning.

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

Retailer CVS and pharmaceutical company Cardinal Health, the concern behind the eyedrops 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 multiple inquiries, including a question about where its eyedrops are made.

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

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

Cardinal Health said, “We are in the process of working with Velocity Pharma and FDA to initiate a recall of all impacted Rugby Laboratories and Cardinal Health Leader branded 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 tested positive for the bacterium Pseudomonas aeruginosa, which is resistant to most antibiotics.

Officials from the CDC and the FDA said most of the cases could be tied to eyedrops made in India and sold under the brands EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma Artificial Eye Ointment, all since recalled.

Fourteen of the 81 people were blinded; an additional four needed at least one eye removed, officials said. Four people ultimately died, they said.

The bacterium found at the facility behind the latest warning was not identified. 

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