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 possible lack of sterility.
The voluntary recall involves four over-the-counter products manufactured by Brassica Pharma, according to an announcement from the Food and Drug Administration 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 expiration dates 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 in the city of Tarapur, about three hours north of Mumbai.
“The products are being recalled due to a lack of sterility assurance at the facility, noted during an inspection by the Food and Drug Administration,” the announcement said. He added that as of February 16, the company had not received any reports of adverse reactions related to these products.
The products are intended 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 recommended consumers stop using more than two dozen over-the-counter eye drop products sold at stores like Target, CVS and Walmart after inspectors found unsanitary conditions at a manufacturing plant. Bacterial tests conducted in critical drug production areas of the plant came back positive.
The manufacturer, Kilitch Healthcare, an Indian company also based in the state of Maharashtra, voluntarily recalled the 27 eye drop products. No adverse effects were reported at the time of withdrawal.
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 strain of drug-resistant bacteria that had been reported. caused at least four deaths and loss of vision in 14 patients.
Eye drops are generally safe, according to experts, who recommend that people talk to their ophthalmologists for recommendations on safe products.
