(NEW YORK) — Consumers are being warned against using more than two dozen eye drop products sold over-the-counter at major retailers including CVS, Target and Rite Aid.
The U.S. Food and Drug Administration says the eye drop products were manufactured in a facility with “insanitary conditions” and carry a “potential risk of eye infections that could result in partial vision loss or blindness.”
“These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the FDA said in a news release Friday. “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.”
The impacted products are marketed under the brands CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma, according to the FDA, which shared a full list of the 26 products on its website.
The federal agency says consumers should “immediately stop using” the products and dispose of them properly, which includes either dropping off the product at a drug take back site or following the FDA’s steps to dispose the product in the trash.
The FDA also says that consumers should not purchase any of the 26 impacted products if they see them on store shelves.
The agency noted it has not yet received any reports of eye infections caused by the eye drop products, but is encouraging health care professional and patients to report any “adverse events or quality problems.”
Target, Rite Aid and CVS are removing the eye drop products from their stores and websites, according to the FDA.
Products branded as Leader, Rugby and Velocity “may still be available” in stores and online and consumers should not purchase those products, the FDA said.
Cardinal Health, the company behind the brands Rugby and Leader, told ABC News it is working to “initiate a recall” of its impacted products.
“FDA notified us of a possible eye infection risk affiliated with some of our Rugby Laboratories and Leader branded eye care products, and immediately upon being notified, we placed all identified impacted eye drop products in our inventory on hold and contacted Velocity Pharma, the supplier of the impacted eye drop products,” Cardinal Health said in a statement. “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 to further safeguard public health and safety.”
The statement continued, “We take FDA’s consumer notification regarding the risk of using impacted Rugby Laboratories and Leader branded eye drop products very seriously. We are working with Velocity Pharma, the supplier of the impacted eye drop products to gain additional insight regarding the unsanitary conditions identified by the FDA at the manufacturing facility.”
Rite Aid confirmed to ABC News that it is removing its impacted products from stores, saying in a statement, “Due to safety concerns identified by the FDA, we are removing the applicable Rite Aid branded products from our store shelves.”
CVS told ABC News the company is offering customers a full refund if they purchased an impacted product.
“Upon receiving notification by FDA, we’ve immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio,” CVS said in a statement. “Customers who purchased these products can return them to CVS Pharmacy for a full refund. We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter.”
ABC News also reached out to Target and Velocity Pharma for comment.
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