Health Alert: Regulators warn drug companies selling unapproved eye products (Full List)

*The United States Food and Drug Administration has sent warning letters to eight drug manufacturing companies, including CVS Health and Walgreens, noting the firms are marketing contaminated eye drops that could be dangerous to health of consumers

Isola Moses | ConsumerConnect

The United States’ Food and Drug Administration (FDA), March 2023, had linked Artificial Tears Lubricant Eye Drops, manufactured by Global Pharma Healthcare and distributed by EzriCare and Delsam Pharma, two at least three deaths and at least eight cases of blindness.

The American country’s health regulatory agency disclosed after contaminated eye drops killed and blinded several consumers earlier this year, it has been cautious about any product consumers put in their eyes.

ConsumerConnect learnt the the food and health regulator had sent warning letters to eight companies, including CVS and Walgreens, saying the companies are marketing unapproved eye products. The agency says the products are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others.

Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility, agency report said.

Jill Furman, Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said: “The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality.

“When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.”

FDA sends warning letters to 8 drug companies

Below is a list of the companies receiving warning letters from the regulator with details about the products in question.

• Boiron Inc.
• CVS Health
• DR Vitamin Solutions
• Natural Ophthalmics, Inc.
• OcluMed LLC
• Similasan AG/Similasan USA
• TRP Company, Inc.
• Walgreens Boots Alliance, Inc.

In regards to do, the FDA says consumers currently using any of these affected eye products should stop using them and speak to their healthcare provider.

The agency said it was particularly concerned that these illegally marketed drug products pose a heightened risk of harm to consumers because drugs applied to the eyes bypass some of the body’s natural defences.

It is also recalled that the FDA, March this year, had linked Artificial Tears Lubricant Eye Drops, manufactured by Global Pharma Healthcare and distributed by EzriCare and Delsam Pharma, two at least three deaths and at least eight cases of blindness.

The product, which was recalled in early 2023, was sold by Amazon, CVS, Target and Walmart.

The Centers for Disease Control and Prevention (CDC) reported 68 cases of infection in 16 states on the US.