The Food and Drug Administration (FDA) is telling consumers to avoid two dozen eye drop products sold at major retailers including CVS and Rite Aid, because they might cause eye infections and potentially result in vision loss.
The 26 products treat dry or irritated eyes and were marketed under the brands CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Velocity Pharma and Goal’s Up & Up brand. They pose a “potential risk of eye infections that might end in partial vision loss or blindness,” based on the FDA.
The warnings from the FDA were prompted after investigators discovered that there have been “insanitary conditions” within the manufacturer’s facility. There have been also positive bacterial test results from environmental sampling of critical drug production areas in the power, the FDA said.
The FDA didn’t name the manufacturer, but CVS and Cardinal Health noted that the products in query were supplied by Velocity Pharma.
Federal health officials said CVS, Rite Aid and Goal are already removing the products from store shelves and their online marketplaces. Nonetheless, regulators cautioned that “products branded as Leader, Rugby and Velocity should be available to buy in stores and online.”
An individual uses a dropper to place artificial tears of their eye.Getty Images/iStockphoto
A spokesperson for CVS told FOX Business in an announcement that it immediately stopped the sale of all products supplied by Velocity Pharma inside the CVS Health Brand Eye Products portfolio after being notified by the FDA. CVS said that buyers who already purchased it could return the product for a refund.
“We’re committed to making sure the products we provide are protected, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter,” the CVS spokesperson said.
Cardinal Health also told FOX Business that it “placed all identified impacted eye drop products in our inventory on hold” and is working with Velocity Pharma and FDA to initiate a recall of all impacted Rugby Laboratories and Cardinal Health Leader branded eye drop products.
The FDA is telling consumers to avoid two dozen brands of eye drops for risk of infection and sight loss. Getty Images/iStockphoto
“We’re working with Velocity Pharma, the supplier of the impacted eye drop products to achieve additional insight regarding the unsanitary conditions identified by the FDA on the manufacturing facility,” Cardinal Health said in an announcement.
Goal, Rite Aid and Velocity Pharma didn’t immediately reply to FOX Business’ request for comment.
The FDA told the manufacturers of the affected products to recall all lots on Oct. 25. The FDA didn’t specify the kind of bacteria that was found during testing.
So far, the agency also has not tied this warning to the prior outbreak of antibiotic-resistant bacteria pseudomonas aeruginosa linked to eye products from Global Pharma Healthcare.
The products “are intended to be sterile.” Nonetheless, the FDA said that there’s a “heightened risk of harm” with ophthalmic drug products, or products pertaining to the attention, because of the proven fact that drugs which can be applied to the eyes bypass a number of the body’s natural defenses.
There haven’t been any reports of eye infections related to those products so far. Nonetheless, consumers who’ve signs or symptoms of an eye fixed infection after using these products are told to hunt medical care “immediately.”
Symptoms of an eye fixed infection include irritated or red eyes, worsening pain in or across the eyes – even after contact lens removal, light sensitivity, sudden blurry vision or unusually watery eyes or discharge, based on the Centers for Disease Control and Prevention.
Patients are encouraged to report any adversarial events or quality problems they’ve with any medicine to the agency’s MedWatch Opposed Event Reporting program.