Walgreens Boots Alliance, Inc.
FDA issued a warning letter to Walgreens Boots Alliance, Inc. on September 11, 2023, regarding three homeopathic ophthalmic products — 'Walgreens Allergy Eye Drops,' 'Walgreens Stye Eye Drops,' and 'Walgreens Pink Eye Drops' — sold on walgreens.com. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) for their labeled uses, and their contract manufacturer was found to have significant CGMP violations rendering the products adulterated. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure, injunction, or detention of products at the U.S. border.
Flagged claims (9)
Relieves redness, burning, watery discharge & sensation of grittiness
[T]emporarily relieve minor symptoms such as: •redness •burning •eyelid redness •tearing
Multi-symptom relief of redness, burning & tearing
For relief of itching, burning, watering & redness of eyes
[T]emporarily relieve minor symptoms associate with styes, such as: redness burning dryness tearing
[T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning
The purpose of this product is to provide temporary relief of stye symptoms
[T]emporarily relieve minor eye allergy symptoms such as: itching burning excessive watering redness of eyes and lids
For irritation, dryness, and burning
Required actions (3)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination.
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