Media Networks Sydney Pty Limited

CLOSEOUT LETTER Media Networks Sydney Pty Limited MARCS-CMS 687044 — September 18, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Gilad Wielunski Media Networks Sydney Pty Limited 36 Mid Dural Rd Galston NSW 2159 Australia info@giftgadget.com.au Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Wielunski: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2716. Based on our evaluation, it appears that you have discontinued your listings for Mylanta 2go Antacid Double Strength (NDC 84177-0801) and Microlax Enema (NDC 84177-0020). Future FDA inspections and 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. If this product is reintroduced in U.S. commercial distribution, FDA expects that all previous errors are corrected. The Agency expects you and your firm to maintain compliance and to 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 & Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Content current as of: 09/23/2024 Regulated Product(s) Drugs