Walgreen Company

CLOSEOUT LETTER Walgreen Company MARCS-CMS 662158 — December 19, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Reference #: 2512 CMS 662158 Product: Drugs Recipient: Recipient Name Jessica Martinez Walgreen Company 200 Wilmot Rd, MS#2114 Deerfield , IL 60015 United States jessica.martinez@walgreens.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Jessica Martinez: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2512 (662158). Based on our evaluation, it appears that you have addressed the deficiencies identified in the warning letter by updating the listing file for Walgreens Sensitive Extra Whitening, NDC 0363-1588. Future FDA regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration cc: Elena Kraus                                Danielle Gray Elena.Kraus@Walgreens.com    Danielle.gray1@wba.com Content current as of: 12/30/2025 Regulated Product(s) Drugs