Contaminated eye drops, ripped from pharmacy shelves over fears they could cause infections and even blindness, were made in an Indian factory where workers walked barefoot and safety test results, according to an explosive report. They were counterfeit.
The 26 over-the-counter products, sold as trademarks at retailers such as CVS, Rite Aid, Walmart and Target, came from a Navi Mumbai company called Kilitch Healthcare India Ltd. according to Bloomberg research.
On October 25, the Food and Drug Administration issued a withdrawal on the more than two dozen brands of eye drops after agency investigators found unsanitary conditions at the India plant and “positive bacterial test results on environmental samples from critical drug production areas at the facility” .
The government report, obtained by Bloomberg, said workers arrived at the factory barefoot or without protective equipment in sterile areas, while one person was observed combing their hair among cleaning equipment and others falsified the dates on products that certified their sterility. . .
The FDA did not immediately respond to a request for comment, but a spokesperson told Bloomberg: “The agency proactively worked with retailers to remove these products from the market before known harm emerged,” Jeremy Kahn said in an email. . “We urge consumers to stop using these products as they could lead to an eye infection.”
It is the second time that US authorities have found problems with eye drops made in India.
In February, health officials discovered that another eye drop manufacturer in India was linked to infections and four deaths and 18 cases of vision loss in the United States.
In that outbreak involving eye drops from EzriCare LLC and Delsam Pharma LLC, which were recalled, dangerous bacteria was found in the products, according to another Bloomberg research.
Four people had their eyeballs removed to stop the spread of the bacteria, while others experienced cloudy corneal abscesses, eye discharge and migraines that lasted for months.
The tainted eye drops came to the US due to a lapse in FDA oversight of over-the-counter drugs that allowed “two inexperienced entrepreneurs” in India to sell their products to distributors and pharmacists in the US. .US, according to the report.
India calls itself the “pharmacy of the world” because it is home to most pharmaceutical manufacturing.
However, the FDA has little power to force a drug manufacturer to recall its products.
But on October 23, it did ban the Kilitch factory from sending any more eye drops to the United States after inspecting the plant for a week, according to Bloomberg.
The agency also asked Kilitch to remove its products, but so far it has not done so, according to the outlet.
The FDA has warned consumers about 78 over-the-counter eye drops this year, but only 13 have been recalled, according to the FDA. Foundation for dry eyesa nonprofit organization in Seattle.
The group raised a red flag in April when it alerted the public about a “sharp increase in eye drops marketed in the U.S. 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 contaminated eye drops could cause “mild to severe” infections that could affect vision and even “progress to a life-threatening infection.”
