FDA Warns 26 Eye Drop Products Could Lead to Eye Infections and Vision Loss

Stores, including CVS, Target, and Walmart, have pulled 26 over-the-counter eye drop products from their shelves after the U.S. Food and Drug Administration (FDA) warned the products could lead to partial vision loss or blindness.

In October, the FDA recommended the products be recalled after its investigators found “insanitary conditions in the manufacturing facility” and bacteria in samples taken from the production plant. Eye drop products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses, according to the FDA.

Several weeks later, Mumbai-based Kilitch Healthcare India voluntarily recalled the eye drop products which had expiration dates ranging from November 2023 to September 2025. Velocity Pharma, the company’s distributor, had distributed the eye drops nationwide.

Citing “safety concerns” by FDA investigators, Kilitch recalled the following eye care products that were marketed under the following brands:

CVS Health

• Lubricant Eye Drops 15 ml (single pack)
• Lubricant Eye Drops 15 ml (twin pack)
• Lubricant Gel Drops 15 ml (single pack)
• Lubricant Gel Drops 15 ml (twin pack)
• Multi-Action Relief Drops 15 ml
• Lubricant Gel Drops 10 ml
• Lubricant Eye Drops 10 ml (single pack)
• Lubricant Eye Drops 10 ml (twin pack)
• Mild Moderate Lubricating Eye Drops 15 mil (single pack)

Leader (Cardinal Health)

• Eye Irritation Relief 15 ml
• Dry Eye Relief 15 ml
• Dry Eye Relief 10 ml
• Lubricant Eye Drops 15 ml (single pack)
• Lubricant Eye Drops 15 ml (twin pack)
• Lubricant Eye Drops 10 ml

Rugby (Harvard Drug Group)

• Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
• Lubricating Tears Eye Drops 0.5 oz (15 ml)

Rite Aid

• Lubricant Eye Drops 15 ml (twin pack)
• Lubricant Eye Drops 10 ml (twin pack)
• Lubricant Gel Drops 15 ml
• Lubricating Gel Drops 10 ml
• Gentle Lubricant Gel Eye Drops 15 ml
• Multi-Action Relief Drops 15 ml

Target

• Up&Up Dry Eye Relief 15 ml (twin pack)
• Up&Up High Performance Lubricant Eye Drops 15 ml (single pack)
• Up&Up High Performance Lubricant Eye Drops 15 ml (twin pack)

Velocity Pharma LLC

• Lubricant Eye Drop 10 ml (triple pack)

Walmart

• Equate Hydration PF Lubricant Eye Drop 10 mL

Although the eye drop products are likely no longer in stores or sold on the stores’ websites, the FDA warned consumers to stop using the products immediately and return them.

The FDA has been particularly vigilant about eye drop enforcement in 2023, according to Gary D. Novak, a clinical professor at University of California (UC) Davis Health, and a clinical pharmacologist with experience in ophthalmic product development.

Novack explained that unlike oral and dermatological products, ophthalmologic products, like eye drops, are supposed to be sterile.

Novack also said that over-the-counter eye drops have a different regulatory process than prescription products. “All the eye drops in this current recall are over-the-counter products. Prescription eye drop products should not be affected,” Novack said in a press release.

Novack also noted that consumers should not be afraid to use eye drops because all of the recalled eye drops should be off the shelves by now.

FDA Issued Other Warnings in 2023 on Eye Drop Products

At the time of the recall in October, the FDA said there had been no reports of injuries from using the products. However, other over-the-counter eye care products recalled earlier in 2023 have caused serious eye injuries and death. The U.S. Centers for Disease Control and Prevention (CDC) worked with the FDA, as well as state and local health departments, to investigate an outbreak of eye infections reported across the country. Most of the patients reported using EzriCare Artificial Tears Lubricant Eye Drops, manufactured by Global Pharma Healthcare in India and distributed by EzriCare and Delsam Pharma.

As of May, the CDC reported more than 80 people infected with aPseudomonas aeruginosa, an antibiotic-resistant strain that had never been reported prior to the outbreak. Of the number of people infected, the CDC reported 14 cases of vision loss, four cases of surgically removed eyeballs, and four deaths.

Jeffrey H. Ma, an ophthalmologist at the UC Davis Eye Center, describes lubricating eye drops, also known as artificial tears, as “the mainstay treatment for dry eye disease.” “Dry eye disease is one of the most common eye diseases and can cause irritation, grittiness, redness, burning, tearing and blurred vision. Artificial tears can help with these symptoms,” Ma said in a press release.

Ma said he recommends to his patients preservative-free drops that come in disposable single-use vials. “So long as people use this product only once, in one or both eyes and discard, preservative-free drops are safe and a great option for dry eyes,” Ma said. “They tend to be gentle on the eyes and can be used more frequently throughout the day.”

Experts Weigh In On Over-The-Counter Eye Care Products

The market for over-the-counter eye care products is largely self-regulated despite the products’ potential for serious injury, according to a paper published in November in the Journal of the American Medical Association (JAMA) Ophthalmology.

However, the vast majority of eye drops sold over-the-counter are safe, Timothy Milton Janetos, the paper’s co-author told USA Today. He said the challenge for both doctors and consumers is evaluating the less than 1 percent risk that an eye drop is contaminated.

In an interview with CNN, Janetos, an assistant professor of ophthalmology at Northwestern University, said it’s “hard for physicians because we get asked all the time, ‘What is safe for me?’”

“I can’t really make a recommendation because there’s really no source of information for me to look at and say, ‘Oh, this is a good eye drop or a bad eye drop.’”

The FDA’s suspension of routine, on-site inspections of drug factories overseas during the first two years of the COVID-19 pandemic is a potential reason why contaminated eye care products were allowed to circulate, the authors wrote in JAMA Ophthalmology said. Although the FDA does not approve over-the-counter eye care products before they are sold on the market, the authors further wrote, “it is the responsibility of the (drug) manufacturers to follow the guidance.. rather than the FDA to enforce it.”

Dr. Christopher Starr, a spokesperson for the American Academy of Ophthalmology, said people should seek medical help immediately if they have adverse reactions to eye drops, such as discharge, redness or pain, which can indicate an infection. People should also check a product’s expiration date before use.

Consumers with questions about the recall can contact Kilitch at regulatory@kilitchhealthcare.com or Velocity Pharma, Kilitch’s distributor, at regulatory@velocitypharma.com. Eye drop users who experience adverse reactions can file a report with the FDA online or by downloading and mailing a pre-addressed form.

Source Links:

https://www.cnn.com/2023/10/30/health/fda-eye-drops-infection-risk/index.html
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential
https://health.ucdavis.edu/news/headlines/fda-eye-drop-recall-dont-use-these-cvs-rite-aid-walmart-and-target-brands/2023/10
https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html
https://www.cnn.com/2023/05/19/health/ezricare-eye-drops-recall-update/index.html
https://www.usatoday.com/story/news/health/2023/11/15/eye-drop-recall-causes-drug-oversight-concerns/71488418007/