Federal regulators are warning consumers to stop using a number of over-the-counter eye drops that may pose an infection risk, marking the latest of several alerts this year against artificial tears.
The notice applies to 26 eye drop products marketed under several store brands, such as CVS Health, Rite Aid and Target Up & Up, in addition to the Leader, Rugby and Velocity Pharma brands, the Food and Drug Administration said Friday. The eye drops may contain bacteria that could cause eye infections, potentially blinding them, the agency said.
The FDA said it has not received any reports of infections from consumers who have used the suspect products. However, the agency is recommending that manufacturers pull all potentially contaminated products from store shelves.
According to the FDA, federal investigators found harmful bacteria and “insanitary conditions” at a manufacturing facility where several eye drop products are produced.
The agency urged consumers who have purchased the potentially contaminated eye drops to discard them. The FDA said that consumers who think they have suffered an adverse reaction to the lubricants should report their concerns to the agency’s MedWatch Adverse Event Reporting program.
The alert follows a series of eye drop recalls the FDA issued earlier this year after federal health investigators found evidence that several products were contaminated with a dangerous drug-resistant bacteria known as Pseudomonas aeruginosa. Eye drops tainted with the bacteria are linked to the death of at least four people, with dozens more affected across 18 states, Centers for Disease Control and Prevention data shows.
“This is infuriating for a few reasons,” Teresa Murray, consumer watchdog at U.S. PIRG Education Fund, in a statement. “First, prior to this FDA warning, there have been three major eye drop recalls this year for bacterial contamination or unsterile products. Why has it taken this long for the FDA to discover this much broader problem?”
“Second, this points to the need for the FDA to have authority to recall unsafe prescriptions and over-the-counter medications when companies — for example, this eye drop manufacturer — refuse to cooperate in a timely fashion,” she added.
The FDA’s latest warning applies to the following eye drop products sold throughout the U.S.
|
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 |
