The U.S. Food and Drug Administration (FDA) has issued a warning concerning over twenty-five over-the-counter eye-drop products available under various brand names, including CVS Health Corp., Target Corp., and Rite Aid Corp. The FDA has underscored that these products carry a risk of causing ocular infections that could potentially result in partial vision impairment or even complete loss of sight.
It is strongly recommended that consumers abstain from procuring or using these products. This encompasses lubricating and dry-eye relief drops marketed under labels such as Velocity Pharma, Cardinal Health Inc.’s Rugby and Leader, in addition to CVS Health, Rite Aid, and Target Up&Up brands.
The FDA’s inquiry uncovered unhygienic conditions in the manufacturing facility of these products. Furthermore, bacterial contamination was detected in crucial stages of the drug production process. The FDA has advised the manufacturer to recall all batches of the affected products.
This recent advisory from the FDA follows a series of safety apprehensions raised about eye products over the course of the year. In the preceding month, CVS and Walgreens Boots Alliance Inc. were cautioned regarding the promotion of unapproved eye products, and concerns were raised about the manufacturing practices of contract manufacturers producing these products. Earlier in the year, several other brands were recalled due to fears of dangerous infections. Additionally, the U.S. Centers for Disease Control and Prevention and the FDA conducted an investigation earlier this year into a multi-state outbreak of drug-resistant bacteria associated with artificial tears products.
While the specific strain of bacteria in this recent advisory was not disclosed by the FDA, the gravity of prior outbreaks has led to heightened scrutiny of the production of eye drops. Patricia Jackson, president of the Association for Professionals in Infection Control and Epidemiology, emphasized that the FDA is actively inspecting manufacturing sites and scrutinizing products, identifying additional brands that may be potentially contaminated.
According to market research firm Statista, an estimated 120 million people in the U.S. use eye drops or eye wash. Eye products present a distinct risk because medications applied to the eyes can bypass certain natural defenses of the body, as highlighted by the FDA.
Individuals who experience symptoms indicative of an eye infection subsequent to using any of the affected products should promptly seek medical attention and consult with their physician. Symptoms to be vigilant for include eye pain, sensitivity to light, abrupt blurriness, redness, discharge, and swelling.
CVS, Target, and Rite Aid have taken measures to remove the products mentioned in the recent advisory from their retail outlets and online platforms. However, products bearing the brands Leader, Rugby, and Velocity may still be available for purchase.
Cardinal Health has responded to the FDA’s notification of the risk of eye infection by placing all affected eye drop products on hold and contacting the supplier, Velocity Pharma. The company is actively collaborating with Velocity Pharma and the FDA to initiate a recall of all impacted Rugby Laboratories and Cardinal Health Leader branded eye products to further ensure public health and safety. Cardinal Health is also working with Velocity Pharma to address the unsanitary manufacturing conditions identified by the FDA.
CVS Health has confirmed the immediate suspension of the sale of all CVS Health brand eye products supplied by Velocity Pharma, both in-store and online. Customers who have purchased these products are encouraged to return them for a full refund. The company is fully cooperating with the FDA on this matter.
Rite Aid has stated that they are currently in the process of removing the affected Rite Aid branded products from store shelves.