Indian eyedrop maker issues recall of various eye drops in US for potential safety reasons
Kilitch Healthcare India Limited recalled 27 variants of eye drops being sold in the United States due to potential safety concerns after FDA investigators found insanitary conditions.
The Food and Drug Administration warned consumers last month not to purchase or use store-brand eyedrops from Walmart Inc., CVS Health Corp., Target Corp. and other companies “due to risk of eye infection,” without naming Kilitch as the manufacturer.
Bloomberg reported Nov. 10 that Kilitch made the eyedrops in an unsanitary factory in India where some workers went barefoot and others fabricated test results that gave the appearance of product safety.
For those patients who use these products, there is a potential risk of eye infections or related harm, said FDA.
These products are intended to be sterile.
Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.
FDA inspectors visited the Kilitch facility for the first time in mid-October where they witnessed several health violations, Bloomberg’s reporting showed.
Among them were microbiologists filling in backdated test results that purported to show batches of eyedrops were sterile. Samples taken during the inspection revealed bacterial contamination in filling areas where the eyedrops were bottled.
On October 25, the FDA requested Kilitch to recall its products, a directive that the company had not complied with until this point.
