Walgreens Boots Alliance, Inc.

Warning LetterOpen

Stefano Pessina Executive Chairman Walgreens Boots Alliance, Inc. 108 Wilmot Rd., MS# 2002 Deerfield , IL 60015 United States Stefano.Pessina@walgreens.comFEI 3004191479Issued Sep 11, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004191479.

Violations1

Issue DateSep 11, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Walgreens Boots Alliance, Inc.
Location: Stefano Pessina Executive Chairman Walgreens Boots Alliance, Inc. 108 Wilmot Rd., MS# 2002 Deerfield , IL 60015 United States Stefano.Pessina@walgreens.com
FEI Number: 3004191479
Country: United States
Issue Date: September 11, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Walgreens Boots Alliance was cited for selling three unapproved ophthalmic drug products—Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, and Walgreens Pink Eye Drops—in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The products were marketed with disease claims (such as relief of itching, burning, watering, and redness of eyes) on the company's website without FDA approval as new drugs. The FDA emphasized that ophthalmic products present heightened public health risk due to direct eye administration, which bypasses the body's natural defenses.

Walgreens Boots Alliance, Inc. FDA Warning Letter, September 11, 2023