Media Networks Sydney Pty Limited Warning Letter Details

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.