Tainted eyedrops yanked from pharmacy shelves over fears they could cause infections and even blindness were made in a factory in India where workers walked around barefoot and safety test results were faked, according to an explosive report.
The 26 over-the-counter products — sold as store brands at retailers including CVS, Rite Aid, Walmart and Target — came from a company in Navi Mumbai called Kilitch Healthcare India Ltd., according to a Bloomberg investigation.
On Oct. 25, the Food & Drug Administration issued a recall on the more than two dozen eyedrop brands after agency investigators found unsanitary conditions at the India plant and “positive bacterial test results from environmental sampling of critical drug production areas in the facility.”
The government report, obtained by Bloomberg, said that workers were showing up to the factory barefoot or were not wearing protective gear in sterile areas while one person was observed combing their hair amidst cleaning equipment and others were forging the dates on products attesting to their sterility.
The FDA did not immediately respond for comment but a spokesman told Bloomberg, “The agency proactively worked with retailers to have these products removed from the market before any known injuries arose,” Jeremy Kahn said in an email. “We urge consumers to stop using these products, as it could result in an eye infection.”
It’s the second time US authorities found problems with eyedrops made in India.
In February, health agents found that another eyedrop maker in India was linked to infections and to four deaths and 18 cases of vison loss in the US.
In that outbreak involving eyedrops from EzriCare LLC and Delsam Pharma LLC – that were recalled – a dangerous bacteria was found in the products, according to another investigation by Bloomberg.
Four people had their eyeballs removed to stop the spread of the bacteria while others experienced cloudy abscesses on their corneas, discharges from their eyes and migraines that lasted for months.
The contaminated eyedrops made their way to the US because of a lapse in the FDA’s supervision of over-the-counter medicines that allowed “two inexperienced entrepreneurs” in India to sell their products to distributors and pharmacists in the US, according to the report.
India bills itself as the “pharmacy to the world” because it is home to most of the pharmaceutical manufacturing.
However, the FDA has little power to force a drugmaker to recall its products.
But it did ban the Kilitch factory on Oct. 23 from sending more eyedrops to the US after inspecting the plant for a week, according to Bloomberg.
The agency also asked Kilitch to recall its products but it hasn’t so far, according to the outlet.
The FDA has warned consumers about 78 over-the-counter eyedrops this year, but only 13 have been recalled, according to the Dry Eye Foundation, a non-profit in Seattle.
The group raised a warning flag back in April when it alerted the public about a “sharp rise in eye drops marketed in the US that may pose health risks to consumers.”
In August, the FDA issued a warning about a “life-threatening infection” associated with Dr. Berne’s Organic Castor Oil Eye Drops; and Dr. Berne’s MSM Mist 15% Solution.
The FDA said the contaminated eyedrops could lead to “minor to serious” infections that could potentially affect vision and even “progress to a life-threatening infection.”