Kilitch Healthcare India Ltd. recalled 27 types of eyedrops sold in U.S. stores nationwide because they may be unsafe, U.S. regulators said.
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.
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.
The FDA asked Kilitch to recall its products on Oct. 25 but the company hadn’t done so until now.
The FDA has little power to force drugmakers to recall products, but on Oct. 23, it banned the Kilitch factory from sending more eyedrops to the U.S.