Four eye ointments withdrawn due to risk of infection

Four eye ointments sold at stores including Walmart and CVS are being recalled due to a potential risk of eye infections or related harm, after US researchers raised concerns about the possible lack of sterility.

The voluntary recall includes four over-the-counter products manufactured by Brassica Pharma, according to a announcement The Food and Drug Administration announced this on Monday.

Two are from Equate, a Walmart brand; one is a CVS Health brand; and another is a brand of AACE Pharmaceuticals. They have an expiration date ranging from February 2024 to September 2025.

Brassica Pharma is a drug development and manufacturing company based in the Indian state of Maharashtra that supplies products to the United States, Europe, Asia and Africa, according to the company’s website. Brassica Pharma’s factory is located in the city of Tarapur, about three hours north of Mumbai.

“The products are being recalled due to a lack of assurance regarding sterility at the facility, as determined during an inspection conducted by the Food and Drug Administration,” the announcement said. It added that as of February 16, the company had not received any reports of adverse events related to these products.

The products are meant to be sterile, the administrator said, because medications applied to the eyes bypass some of the body’s natural defense systems.

Other eye products have been recalled in recent months.

In October, the FDA advised consumers to stop using more than two dozen over-the-counter eye drop products sold at stores such as Target, CVS and Walmart after inspectors found unsanitary conditions at a factory. Bacterial tests came back positive from critical drug production areas at the plant.

The manufacturer, Kilitch Healthcare, an Indian company also based in the state of Maharashtra, then voluntarily called the 27 eye drop products. No adverse effects were reported at the time of the recall.

Early last year, the Centers for Disease Control and Prevention and the FDA warned consumers to stop using two eye drop products after they were linked to a drug-resistant strain of bacteria found to have caused at least four deaths and vision loss in 14 patients .

Eye drops are generally safe, according to experts, who recommend people talk to their ophthalmologist to get recommendations for safe products.