Kilitch Healthcare India Ltd. has recalled 27 types of eye drops sold in U.S. stores across the country because they may be unsafe, U.S. regulators said.
The Food and Drug Administration last month warned consumers not to buy eye drops from Walmart Inc., CVS Health Corp., Target Corp. and to purchase or use other companies “due to the risk of eye infections,” without naming Kilitch as the manufacturer.
Bloomberg reported on November 10 that Kilitch made the eye drops 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 first visited the Kilitch facility in mid-October, where they witnessed several health violations, Bloomberg reporting showed. Among them were microbiologists who filed outdated test results that purported to show that batches of eye drops were sterile. Samples taken during the inspection revealed bacterial contamination in the filling areas where the eye drops were bottled.
The FDA asked Kilitch to recall its products on October 25, but the company had not done so until now. The FDA has little power to force drugmakers to recall products, but on October 23 it banned the Kilitch factory from sending any more eye drops to the US.
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Updated: Nov 16, 2023 06:21 IST