The Food and Drug Administration on Monday expanded its warning against buying or using eye drops sold by some major retailers, sometimes under their own brand names.
According to the FDA, the warning also includes a product sold by Walmart, Equate Hydration PF Lubricating Eye Drops 10mL. “Walmart is removing the product from its stores and website,” it said in its latest drug safety alert.
a list of eye drops Those released under the FDA warning include those sold under the CVS Health, Leader, Rugby, Rite Aid, Target Up & Up, and Velocity Pharma brands.
The agency said retailers should remove the products from their shelves and consumers should throw them away. In addition to Walmart’s notable cooperation, the FDA said CVS, Target, and Rite Aid are removing the eye drops from their shelves and making them unavailable on their websites.
The FDA said infection and vision loss are possible, but it has not received any reports of either. The alarm was raised after inspectors found contamination in the production area.
“FDA announced on October 10, 2023 after agency investigators found unsanitary conditions within the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas within the facility. “We advised the manufacturers of these products to recall all batches on March 25,” it said in the warning. .
The agency did not mention the manufacturer or the location of the facility. Last week, the company advised manufacturers to recall the products, but it is unclear whether they have responded.
Retailer CVS and pharmaceutical company Cardinal Health, the concern behind the eye drops sold under the Leader and Rugby brands, both said separately that the supplier is Velocity Pharma LLC.
Velocity Pharma is based in Farmingdale, New York. The company did not respond to multiple inquiries, including questions about where the eye drops are manufactured.
The FDA did not respond to inquiries regarding the location of the facility where the allegedly unsanitary conditions were located.
CVS said in a statement that it immediately stopped selling the eye drops after receiving the FDA warning. “Customers who purchased these products may return them to CVS Pharmacy for a full refund.”
“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,” Cardinal Health said in a statement. Ta.
Walmart and Target did not respond to requests for comment.
Earlier this year, the Centers for Disease Control and Prevention announced that 81 people in 18 states had tested positive for the virus. Pseudomonas aeruginosaresistant to most antibiotics.
CDC and FDA officials said most of the cases are linked to eye drops manufactured in India and sold under the brands Ezricare Artificial Tears, Delsum Pharma Artificial Tears, and Delsum Pharma Artificial Eye Ointment. All have since been recalled.
14 of the 81 patients were blind. Four more will need at least one eye removed, officials said. In the end, four people died.
The bacteria found at the facility behind the latest warning has not been identified.