Kilitch Healthcare India recalls various eye drops in US over vision loss and blindness concerns

According to USFDA, for those patients who use the aforementioned products of Kilitch Healthcare, there is a potential risk of eye infections or related harm. “These products are intended to be sterile. Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defences,” it said.

The regulator directed distributors and retailers that have any product which is being recalled to cease their distribution. It also advised consumers to stop using the recalled eye drops and that they may return any of the affected products to the place of purchase.

The USFDA has said consumers should not use the products due to the risk of vision loss or blindness.

USFDA had 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. It also recommends consumers to properly discard these products.

On October 27, USFDA warned 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 eye infection after using these products should talk to their healthcare provider or seek medical care immediately, it said.

The products were marketed under the brands — CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up and Velocity Pharma.

CVS (seven products), Rite Aid (six products) and Target (three products) are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available in stores and online and should not be purchased, the regulator said.

According to a Bloomberg report, the USFDA warned consumers in October not to purchase or use store-brand eye drops from Walmart Inc, CVS Health Corp, Target Corp. and other companies “due to risk of eye infection,” without naming Kilitch as the manufacturer.

Bloomberg reported on November 10 that Kilitch made the eyedrops in an unsanitary factory in India where some workers went barefoot and others fabricated test results that gave the appearance of product safety.