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FDA warns against using 26 eye drop products due to infection risk


FDA warns against using 26 eye drop products due to infection risk

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Another eye drop recall is pulling 27 products from store shelves, including store-brand products sold at retailers such as CVS, Rite Aid, Target and Walmart, with the recall coming about three weeks after the U.S. Food and Drug Administration warned people not to buy or use the eye drops.

Kilitch Healthcare India is recalling eye drops with expiration dates ranging from November 2023 to September 2025, citing “potential safety concerns after FDA investigators found insanitary conditions,” according to a news release posted Wednesday by the FDA. You can see the full list of recalled eye drops here.

The FDA cited a “risk of eye infections that could result in partial vision loss or blindness” in urging against use of the products in late October, with the agency saying its investigators found unsanitary conditions and “positive bacterial test results” from areas of an unidentified manufacturing facility.

Some of the eye drops may have already been removed from stores, as earlier this month the FDA said CVS, Rite Aid and Target were taking the products off their shelves and websites. 

The recall notice said that distributors and retailers that have any of the recalled products should stop distributing them. Consumers, meanwhile, should stop using the recalled eye drops and return the products to where they purchased them, the FDA said.

Unsanitary conditions

Bloomberg News reported that Kilitch produced the eye drops in an unsanitary factory in India where some workers went barefoot and others made up test results that purported to show the products were sterile. 

The FDA’s warning prompted Cardinal Health in early November to recall six Leader brand eye products, while Harvard Drug Group recalled Rugby Laboratories brand eye drops. 

The FDA earlier this year announced a spate of recalls of eye drop products linked to four deaths and multiple cases of vision loss. In August, it warned against using two additional eye drop products because of the risk of bacterial or fungal contamination. 

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