An unsanitary factory in India manufactured over-the-counter eye drops that the FDA last month warned consumers to stop using, according to inspection reports obtained by Bloomberg.
In late October, the FDA issued an alert warning consumers to stop using 26 eye drop products because of potential risk of infection that could lead to partial vision loss or blindness. Major retailers including CVS Health, Target and Walmart carried the products as store brands and were directed by federal regulators to pull products from store shelves.
According to an inspection report reviewed by Bloomberg, the products were made by Kilitch Healthcare India, which the FDA did not name in its Oct. 27 consumer alert. Inspectors with the agency visited the Kilitch facility in India for the first time in mid-October and found workers barefoot. Inspectors also reportedly saw workers not donning proper protective gear in sterile areas and observed them fabricating test results so products appeared safe. Test results from environmental sampling showed critical drug production areas were contaminated with bacteria.
"The agency proactively worked with retailers to have these products removed from the market before any known injuries arose," an FDA spokesperson told Bloomberg in a Nov. 9 report. "We urge consumers to stop using these products, as it could result in an eye infection."
In its consumer alert, the FDA said it had not yet received any reports of adverse events linked to the products. Cardinal Health later said it received three reports of adverse effects, according to Bloomberg.