WARNING LETTER
Media Networks Sydney Pty Limited
MARCS-CMS 687044 —
August 15, 2024
Reference #:
2716
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
WARNING LETTER
Date: August 15, 2024
RE: WL# 2716
Dear Gilad Wielunski:
This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for the following drug products:
1
84177-0801 Mylanta 2go Antacid Double Strength
84177-0020 Microlax Enema
Your firm has not fulfilled its listing obligations under section 510(j) of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, these drugs are not properly listed with FDA causing them to be misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
Drug Listing Violations
Section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 outline the requirements for registration and listing of drug products. The listing file for drug listing must include the name and quantity of each active pharmaceutical ingredients as required under section 510(j)(1)(c) of the FD&C Act, 21 U.S.C. 360(j)(1)(c), and 21 CFR 207.49(a)(4). In the listing file submitted to FDA for these drug products, the active ingredients list included in the labeling does not match the active ingredient list included in the electronic listing file. Specifically, for the listing of Mylanta 2go Antacid Double Strength, NDC 84177-0801, the active ingredients included in the package labeling are aluminum hydroxide, magnesium hydroxide, and simethicone. However, the electronic listing file only includes aluminum hydroxide and dimethiconol as the active ingredients while including magnesium hydroxide as an inactive ingredient.
With regard to the listing of Microlax Enema, NDC 84177-0020, the active ingredients described in the package labeling include sodium citrate, sodium lauryl sulfoacetate, and sorbitol. However, the electronic listing file only includes sorbitol as the active ingredient and sodium lauryl sulfoacetate and sodium citrate (trisodium citrate dihydrate) as inactive ingredients.
Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, Mylanta 2go Antacid Double Strength (NDC 84177-0801), and Microlax Enema (NDC 84177-0020) are not properly listed with the FDA, causing them to be misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.
We note that this warning letter only addresses registration and listing issues associated with your products. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the products into compliance. It is also your responsibility to correct listing deficiencies with all other products distributed by your firm.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov. for further assistance. Include the case identification number 2716 on all correspondence.
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
__________________________
1
On April 8, 2024, we sent you a drug listing deficiency letter notification describing the observed listing deficiencies in the information you submitted. On May 23, 2024, we sent you a data removal email notification informing you of a data removal action. As stated in that email, the continued deficiencies resulted in your product’s data removal from FDA’s Online NDC Directory. FDA sends data deficiency letters and data removal notifications to the contact person found in the labeler code SPL submitted by your firm to FDA. If this information has changed, it is your responsibility to update this within 30 days of any change, under 21 CFR 207.33(c).
Content current as of:
08/20/2024
Regulated Product(s)
Drugs