WASHINGTON (AP) — U.S. health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness.
The Food and Drug Administration advisory applies to lubricating drops sold by six companies, including CVS Health, Target, Rite Aid, and Cardinal Health. Consumers should stop using the products immediately and avoid purchasing any that remain on pharmacy and store shelves, the FDA said in a statement Friday.
The agency asked the companies to recall their products last week because FDA inspectors found unsanitary conditions and bacteria at the facility producing the drops. The FDA did not disclose the location of the factory or when it was inspected.
No injuries related to the products had been reported at the time of the announcement, but the FDA encouraged doctors and patients to submit cases through the agency’s online reporting system.
Earlier this year, federal officials linked an outbreak of drug-resistant bacteria to eyedrops from two companies, EzriCare and Delsam Pharma. More than 80 people in the U.S. tested positive for eye infections from the rare bacterial strain, according to the most recent update from the Centers for Disease Control and Prevention.
After the products were recalled in February, health inspectors visited the manufacturing plant in India that made the eyedrops and uncovered problems with how they were made and tested, including inadequate sterility measures.
Here’s the complete list from the FDA:
FDA 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 potentially 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, 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. 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 health care 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.
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
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