by Connected media – Linked media
“The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration,” the announcement said. It added that, as of Feb. 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 drugs 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 F.D.A. advised consumers to stop using more than two dozen over-the-counter eyedrop products sold at stores including Target, CVS and Walmart after inspectors found unsanitary conditions at a manufacturing plant. Bacterial tests came back positive from critical drug production areas in the plant.
The manufacturer, Kilitch Healthcare, an Indian company also based in the state of Maharashtra, then voluntarily recalled the 27 eyedrop products. No adverse effects were reported at the time of the recall.
Early last year, the Centers for Disease Control and Prevention and the F.D.A. warned consumers to stop using two eyedrop products after they were tied to a drug-resistant bacteria strain found to have caused at least four deaths and vision loss in 14 patients.
Associated media – Associated media
