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FDA Warning: Certain Eye Drops Cause Eye Infection

 

Last updated 11/21/2023 at 1:37pm



The Food and Drug Administration is warning consumers not to purchase and to immediately stop using 27 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. These products are marketed under the following brands:

CVS Health

Leader (Cardinal Health)

Rugby (Cardinal Health)

Rite Aid

Target Up & Up

Velocity Pharma

Walmart

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.

FDA recommended the manufacturer of these products recall all lots on October 25, 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. Walmart is removing the product from their store shelves and website.

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.

CVS Health:

Lubricant Eye Drops 15 ml (single pack)

Lubricant Eye Drops 15 ml (twin pack)

Lubricant Gel Drops 15 ml (single pack)

Lubricant Gel Drops 15 ml (twin pack)

Multi-Action Relief Drops 15 ml

Lubricating Gel drops 10 ml

Lubricant Eye Drops 10 ml (single pack)

Lubricant Eye Drops 10 ml (twin pack)

Mild Moderate Lubricating Eye Drops 15 ml (single pack)

Rugby (Cardinal Health):

Lubricating Tears Eye Drops 15 ml

Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml

Leader (Cardinal Health):

Dry Eye Relief 10 ml

Lubricant Eye Drops 15 ml (single pack)

Lubricant Eye Drops 15 ml (twin pack)

Dry Eye Relief 15 ml

Eye Irritation Relief 15 ml

Rite Aid:

Lubricant Eye Drops 15 ml (twin pack)

Lubricant Eye Drops 10 ml (twin pack)

Gentle Lubricant Gel Eye Drops 15 ml

Lubricant Gel Drops 15 ml

Lubricating Gel Drops 10 ml

Multi-Action Relief Drops 15 ml

Target:

Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml

Up&Up Extreme Relief Dry Eye 15 ml (single pack)

Up&Up Extreme Relief Dry Eye 30 ml (twin pack)

Velocity Pharma LLC:

Lubricant Eye Drop 10 ml (triple pack)

Walmart:

Equate Hydration PF Lubricant Eye Drop 10 ml

 
 
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