The U.S. Food and Drug Administration (FDA) warned consumers not to purchase and immediately stop using more than two-dozen eye drop products sold at major retailers.
“FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately,” the FDA wrote last week.
“FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website,” the FDA noted Monday.
The FDA is warning consumers against using more than two dozen eye drop products sold at major retailers including CVS, Target and Rite Aid that carry a "potential risk of eye infections that could result in partial vision loss or blindness." https://t.co/3NUjGAx81G
— ABC News (@ABC) October 30, 2023
According to the FDA, these products are marketed under the following brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target Up & Up
- Velocity Pharma
The FDA writes:
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.Advertisement
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. FDA also recommends consumers properly discard these products.
CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.
FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program.
— CBS Mornings (@CBSMornings) October 31, 2023
Good Morning America writes:
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.”
The FDA included a full list of the products on its website.