FDA WARNING_LETTER - Media Networks Sydney Pty Limited - August 20, 2024

The FDA issued a Warning Letter to Gilad Wielunski on August 15, 2024 (WL# 2716) regarding drug listing violations for Mylanta 2go Antacid Double Strength (NDC 84177-0801) and Microlax Enema (NDC 84177-0020). The firm failed to fulfill drug listing obligations under section 510(j) of the FD&C Act, a prohibited act under section 301(p). These drugs are also misbranded under section 502(o), making their introduction into interstate commerce prohibited under section 301(a).

Specifically, the electronic listing files for both products do not match the active ingredients listed in their package labeling. For Mylanta 2go, the labeling lists aluminum hydroxide, magnesium hydroxide, and simethicone as active, while the eDRLS lists only aluminum hydroxide and dimethiconol as active, with magnesium hydroxide as inactive. For Microlax Enema, the labeling lists sodium citrate, sodium lauryl sulfoacetate, and sorbitol as active, but the eDRLS lists only sorbitol as active, with sodium lauryl sulfoacetate and sodium citrate as inactive.

The FDA emphasizes that accurate drug listing is crucial for patient safety, inspections, supply chain security, and post-market surveillance. The firm was previously