The warnings pertain to unapproved ophthalmic products marketed to treat conditions such as conjunctivitis, cataracts, and glaucoma. Letters were sent to CVS Health, Walgreens Boot Alliance, Boiron, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan AG, and TRP Company.
“The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the agency said in a news release, noting that some of the products contain silver, which can cause the eye and other areas of the skin to turn gray overtime.
The products affected include “CVS Health Pink Eye Relief Drops” and three Walgreens’ products: allergy eye drops, stye eye drops and pink eye drops.
The companies have 15 days to respond and address how they will correct the violations. The FDA said failure to correct violations in a timely manner could result in legal action.
Read more here.
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