Gilad Wielunski
Media Networks Sydney Pty Limited
36 Mid Dural Rd
Galston NSW 2159
Australia
info@giftgadget.com.auIssued Aug 15, 2024Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations3
Issue DateAug 15, 2024
Product TypeOther
StatusClosed
Closeout LetterSep 23, 2024
Letter Details
Firm
Media Networks Sydney Pty Limited
Location
Gilad Wielunski
Media Networks Sydney Pty Limited
36 Mid Dural Rd
Galston NSW 2159
Australia
info@giftgadget.com.au
FEI Number
N/A
Country
Australia
Issue Date
August 15, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Other
Status
Closed
Closeout Letter
September 23, 2024
Summary
Media Networks Sydney Pty Limited failed to properly register and list two drug products—Mylanta 2go Antacid Double Strength and Microlax Enema—in violation of section 510(j) of the FD&C Act. The company's electronic listing files contained mismatched active ingredient information compared to the product labeling; for example, Mylanta 2go listed only aluminum hydroxide and dimethiconol electronically while the package label identified aluminum hydroxide, magnesium hydroxide, and simethicone as active ingredients. These discrepancies resulted in the drugs being misbranded and their introduction into interstate commerce being prohibited under section 301(a) of the FD&C Act.
Media Networks Sydney Pty Limited FDA Warning Letter, August 15, 2024