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FDA warns of eye infection risk from certain OTC eye drops from several major brands

The FDA warning includes 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness.
Sandra Levy
Senior Editor
Levy

The Food and Drug Administration is warning 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 an eye infection after using these products should talk to their healthcare 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

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 Oct. 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.

FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages healthcare professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:

Complete and submit the report online at Medwatch; or

Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Retailer/ Label

ProductProduct Information
CVS HealthLubricant 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 mlPolyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Lubricating Gel drops 10 mlPolyethylene 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 mlPolyvinyl Alcohol Eye Drops 1.4% w/v
Leader (Cardinal Health)Dry Eye Relief 10 mlPolyethylene 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 mlCarboxymethylcellulose Sodium Eye Drops 1% w/v
Eye Irritation Relief 15 mlPolyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
Rite AidLubricant 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 mlHypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye Drops
Lubricant Gel Drops 15 mlCarboxymethylcellulose Sodium Eye Drops 1% w/v
Lubricating Gel Drops 10 mlPolyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops
Multi-Action Relief Drops 15 mlPolyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops
TargetUp&Up Dry Eye Relief Lubricant Eye Drops 30 mlPolyethylene 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 LLCLubricant Eye Drop 10 ml (triple pack)Propylene Glycol Eye Drops 0.6% w/v
 

 

 

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