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FDA warns consumers to stop using dozens of over-the-counter eye drops

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October 30, 2023
in Health Care
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FDA warns consumers to stop using dozens of over-the-counter eye drops
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(WHTM) – The U.S. Food and Drug Administration is urging consumers to stop using 26 over-the-counter eye drop products from multiple major brands due to the risk of eye infections that may lead to vision loss or blindness.

The FDA first posted the warning Friday, explaining that officials had already urged the manufacturer to recall the affected products days before. The move came “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,” the FDA wrote.


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The eye drop products were marketed under the following brands:

CVS Health

Leader (Cardinal Health)

Rugby (Cardinal Health)

Rite Aid

Target Up&Up

Velocity Pharma

CVS, Rite Aid and Target were in the process of removing the affected products from sale as of Friday, according to the FDA. The agency said, however, that Rugby, Leader and Velocity Pharma products may still be on the market.

The specific products affected by the warning are listed below.

Retailer/ Label
Product
Product Information

CVS Health
Lubricant Eye Drops 15 ml (single pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% w/v

Lubricant Eye Drops 15 ml (twin pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% w/v

Lubricant Gel Drops 15 ml (single pack) 
Carboxymethylcellulose Sodium Eye Drops 1% w/v

Lubricant Gel Drops 15 ml (twin pack)
Carboxymethylcellulose Sodium Eye Drops 1% w/v

Multi-Action Relief Drops 15 ml
Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops

Lubricating Gel drops 10 ml
Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops

Lubricant Eye Drops 10 ml (single pack)
Propylene Glycol Eye Drops 0.6% w/v

Lubricant Eye Drops 10 ml (twin pack)
Propylene Glycol Eye Drops 0.6% w/v

Mild Moderate Lubricating Eye Drops 15 ml (single pack) 
Polyethylene Glycol 400 Eye Drop ‘0.25% w/v

Rugby (Cardinal Health)
Lubricating Tears Eye Drops 15 ml    
Hypromellose 2910-0.3% w/v & Dextran 70- 0.1% Eye Drops

Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
Polyvinyl Alcohol Eye Drops 1.4% w/v

Leader (Cardinal Health)
Dry Eye Relief 10 ml
Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops

Lubricant Eye Drops 15 ml (single pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% w/v

Lubricant Eye Drops 15 ml (twin pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% w/v

Dry Eye Relief 15 ml
Carboxymethylcellulose Sodium Eye Drops 1% w/v

Eye Irritation Relief 15 ml
Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops

Rite Aid
Lubricant Eye Drops 15 ml (twin pack)
Carboxymethylcellulose Sodium Eye Drops 0.5% w/v

Lubricant Eye Drops 10 ml (twin pack)
Propylene Glycol Eye Drops 0.6% w/v

Gentle Lubricant Gel Eye Drops 15 ml
Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye Drops

Lubricant Gel Drops 15 ml
Carboxymethylcellulose Sodium Eye Drops 1% w/v

Lubricating Gel Drops 10 ml
Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops

Multi-Action Relief Drops 15 ml
Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops

Target
Up&Up Dry Eye Relief Lubricant Eye Drops 30 ml
Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops

Up&Up Extreme Relief Dry Eye 15 ml (single pack)
Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops

Up&Up Extreme Relief Dry Eye 30 ml (twin pack)
 Carboxymethylcellulose Sodium Eye Drops 0.5% w/v

Velocity Pharma LLC
Lubricant Eye Drop 10 ml (triple pack)
Propylene Glycol Eye Drops 0.6% w/v

As of Oct. 27, the FDA has not received any “adverse event reports of eye infection” connected with the eye drops.

Still, the agency is telling consumers to discard the drops.

Consumers and health providers should also report any negative reactions to the FDA’s MedWatch Adverse Event Reporting program, either online or via fax.

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