FDA warns consumers of infection risk in over-the-counter eyedrops

The FDA warns against using over two dozen over-the-counter eyedrops due to infection risk, potentially leading to blindness. This advisory includes lubricating drops from six companies, like CVS Health and Target, and urges consumers to stop usin...

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FILE - A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. The first gene therapy for Duchenne muscular dystrophy received preliminary U.S. approval on Thursday, June 22, 2023, despite concerns from some government scientists about the treatment's ability to help boys with the inherited disease. (AP Photo/Manuel Balce Ceneta, File)
The Food and Drug Administration has warned consumers to avoid using over two dozen varieties of over-the-counter eyedrops because of the risk of infection that could eventually lead to blindness.

The advisory applies to lubricating drops and it includes lubricating drops sold by six companies, including eye drops from CVS Health, Target, Rite Aid, and Cardinal Health. The FDA has asked consumers to stop using these products immediately and should avoid purchasing any of the remaining products that remain on pharmacy shelves.

The FDA's move comes in the wake of their request to the aforementioned companies to initiate a recall of their eyedrop products. The reason for the recall was because FDA inspectors found the products made in unsanitary conditions. The facility producing the drops was also bacteria ridden. However the FDA has not disclosed the location of the factor 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, health officials at the federal level were able to establish a connection between an outbreak of drug-resistant bacteria and certain eyedrops from two companies, namely EzriCare and Delsam Pharma. This outbreak resulted in more than 80 confirmed cases of eye infections caused by an uncommon bacterial strain within the United States.

Following the recall of these products in February, health inspectors conducted a thorough examination of the manufacturing facility in India responsible for the production of these eyedrops. This investigation revealed several issues related to the manufacturing and testing processes, with a particular focus on inadequate sterility measures.
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