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 in a series of alerts this year. against artificial tears.
The notice applies to 26 eye drop products marketed under several commercial 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 announced Friday. Eye drops may contain bacteria that can cause eye infections or even blindness, the agency said.
The FDA said it had not received any reports of infections from consumers who used the suspect products. However, the agency recommends that manufacturers remove all potentially contaminated products from store shelves.
According to the FDA, federal investigators discovered harmful bacteria and “unsanitary conditions” at a manufacturing plant where several eye drop products are made.
The agency urged consumers who purchased potentially contaminated eye drops to throw them away. The FDA said consumers who believe they have experienced an adverse reaction to 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 released 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 contaminated with bacteria linked to death at least four peoplewith dozens more affected in 18 states, according to data from the Centers for Disease Control and Prevention.
“This is infuriating for several reasons,” Teresa Murray, consumer watchdog at the US PIRG Education Fund, said in a statement. “First of all, before this warning from the FDA, there were three major eye drop recalls this year for bacterial contamination or non-sterile products. Why did it take the FDA so long to discover this problem much larger?”
“Second, it underscores the need for the FDA to have the authority to recall dangerous prescription and over-the-counter drugs when companies – for example, this eye drop manufacturer – refuse to cooperate in a timely manner,” he said. she added.
FDA’s latest warning applies to the following eye drops sold in the United States
|
Retailer/Label |
Product |
Product information |
|
CVS Health |
Lubricating eye drops 15 ml (single pack) |
Carboxymethyl Cellulose Sodium Eye Drops 0.5% w/v |
|
Lubricating eye drops 15 ml (double pack) |
Carboxymethyl Cellulose Sodium Eye Drops 0.5% w/v |
|
|
Lubricating gel drops 15 ml (individual packaging) |
Carboxymethyl Cellulose Sodium Eye Drops 1% w/v |
|
|
Lubricating gel drops 15 ml (double pack) |
Carboxymethyl Cellulose Sodium Eye Drops 1% w/v |
|
|
Multi-action relief drops 15 ml |
Polyvinyl alcohol 0.5% w/v and povidone 0.6% w/v and tetrahydrozoline hydrochloride 0.05% eye drops |
|
|
Lubricating gel drops 10 ml |
Polyethylene glycol 400 0.4% and propylene glycol 0.3% eye drops |
|
|
Lubricating eye drops 10 ml (single pack) |
Propylene Glycol Eye Drops 0.6% w/v |
|
|
Lubricating eye drops 10 ml (double pack) |
Propylene Glycol Eye Drops 0.6% w/v |
|
|
Light and Moderate Lubricating Eye Drops 15ml (Single Pack) |
Polyethylene Glycol Eye Drop 400′ 0.25% w/v |
|
|
Rugby (Cardinal Health) |
Lubricating Tears Eye Drops 15 ml |
Hypromellose 2910-0.3% w/v and 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 10ml |
Polyethylene glycol 400 0.4% and propylene glycol 0.3% eye drops |
|
Lubricating eye drops 15 ml (single pack) |
Carboxymethyl Cellulose Sodium Eye Drops 0.5% w/v |
|
|
Lubricating eye drops 15 ml (double pack) |
Carboxymethyl Cellulose Sodium Eye Drops 0.5% w/v |
|
|
Dry Eye Relief 15 ml |
Carboxymethyl Cellulose Sodium Eye Drops 1% w/v |
|
|
Eye irritation relief 15 ml |
Polyvinyl alcohol 0.5% w/v and povidone 0.6% w/v and tetrahydrozoline hydrochloride 0.05% eye drops |
|
|
Help with rites |
Lubricating eye drops 15 ml (double pack) |
Carboxymethyl Cellulose Sodium Eye Drops 0.5% w/v |
|
Lubricating eye drops 10 ml (double pack) |
Propylene Glycol Eye Drops 0.6% w/v |
|
|
Gentle Lubricating Gel Eye Drops 15 ml |
Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye drops |
|
|
Lubricating Gel Drops 15 ml |
Carboxymethyl Cellulose Sodium Eye Drops 1% w/v |
|
|
Lubricating Gel Drops 10 ml |
Polyethylene glycol 400 0.4% and propylene glycol 0.3% eye drops |
|
|
Multi-action relief drops 15 ml |
Polyvinyl alcohol 0.5% w/v and povidone 0.6% w/v and tetrahydrozoline hydrochloride 0.05% eye drops |
|
|
Target |
Up&Up Lubricant for Dry Eye Relief, Eye Drops 30 ml |
Polyethylene glycol 400 0.4% and propylene glycol 0.3% eye drops |
|
Up&Up Extreme Dry Eye Relief 15 ml (single pack) |
Polyethylene glycol 400 0.4% and propylene glycol 0.3% eye drops |
|
|
Up&Up Extreme Dry Eye Relief 30ml (double pack) |
Carboxymethyl Cellulose Sodium Eye Drops 0.5% w/v |
|
|
Velocity Pharma, LLC |
Lubricating eye drop 10 ml (triple pack) |
Propylene Glycol Eye Drops 0.6% w/v |
#FDA #Warns #Consumers #Eye #Drops #Due #Risk #Infection
Image Source : www.cbsnews.com