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Home News

FDA updates warning for contaminated eyedrop products

by Staff Writer
November 3, 2023
in FDA, News, Ophthalmic insights, Policy & regulation
Reading Time: 3 mins read
A A
FDA updates warning for contaminated eyedrop products

The product warnings come amid a host of adverse events associated with contaminated eyedrops earlier this year.

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The US Food and Drug Administration (FDA) has issued product warnings for an additional 27 over-the-counter eyedrop products due to the potential risk of eye infections that could result in partial vision loss or blindness.

These warnings have been issued after bacterial contamination of artificial tears were linked to a series of hospitalisations earlier in 2023, including 14 patients with vision loss, an additional four requiring enucleation, and four deaths.

In a statement released by the FDA, the products are intended to be sterile as drugs applied to the eyes bypass some of the body’s natural defences.

The FDA has recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility. Furthermore, the FDA said that critical drug production areas in the facility tested positive for bacterial results.

According to the statement, the FDA has not received any adverse reports of eye infection linked to these products.

The FDA recommends that consumers properly discard these products according to their guidelines.

Updated eyedrop retailers and product information:

  • CVS Health
    • Lubricant Eye Drops 15ml (single pack)
    • Lubricant Eye Drops 15ml (twin pack)
    • Lubricant Gel Drops 15ml (single pack)
    • Lubricant Gel Drops 15ml (twin pack)
    • Multi-Action Relief Drops 15ml
    • Lubricating Gel drops 10 ml
    • Lubricant Eye Drops 10ml (single pack)
    • Lubricant Eye Drops 10ml (twin pack)
    • Mild Moderate Lubricating Eye Drops 15ml (single pack)
  • Rugby (Cardinal Health)
    • Lubricating Tears Drops 15ml
    • Polyvinyl Alcohol 1.4% Lubricating Eye Drops
  • Leader (Cardinal Health)
    • Dry Eye Relief 10ml
    • Lubricant Eye Drops 15ml (single pack)
    • Lubricant Eye Drops 15ml (twin pack)
    • Dry Eye Relief 15ml
    • Eye Irritation Relief 15ml
  • Rite Aid
    • Lubricant Eye Drops 15ml (twin pack)
    • Lubricant Eye Drops 10ml (twin pack)
    • Gentle Lubricant Gel Eye Drops 15ml
    • Lubricant Gel Drops 10ml
    • Multi-Action Relief Drops 15ml
  • Target
    • Up&Up Dry Eye Relief Lubricant Eye Drops 30ml
    • Up&Up Extreme Relief Dry Eye 15ml (single eye)
    • Up&Up Extreme Relief Dry Eye 30ml (twin pack)
  • Velocity Pharma LLC
    • Lubricant Eye Drop 10ml (triple pack)
  • Walmart
    • Equate Hydration PF Lubricant Eye Drop 10ml

More reading 

FDA warning to companies marketing unapproved ophthalmic drug products

Tracing the contaminated eye drops saga

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