CVS Health
FDA issued a warning letter to CVS Health (President & CEO Karen S. Lynch) on September 11, 2023, regarding its 'CVS Health Pink Eye Relief Drops,' a homeopathic ophthalmic product sold on cvs.com. FDA determined the product is an unapproved new drug under FD&C Act section 505(a) because it is not generally recognized as safe and effective for its labeled uses, and also deemed adulterated due to CGMP violations at its contract manufacturer. FDA further flagged safety concerns about the use of silver sulfate as a preservative. CVS was directed to respond within 15 working days with corrective steps, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (4)
CVS Health Pink Eye Drops is a homeopathic formula that stimulates the body's ability to relieve redness, burning, watery discharge, and sensations of grittiness.
[T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning
When your eyes are dry, itching, or burning, it can be a big problem that you want relief from right away. These Irritated Eye Drops from CVS Health can provide you with the rapid relief you need . . . They are very helpful for relieving irritation, redness, burning, and dryness. The homeopathic formula is safe for use in the eyes and easy to apply . . . These drops are gentle enough for frequent use and even for use on children.
Relieves •Redness •Burning •Watery discharge •Gritty sensation
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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