REGULATORY INTELLIGENCE·Warning Letter
Haleon US Holdings LLC Faces FDA Scrutiny Over Gaviscon Labeling Non-Compliance, Prompting Nationwide Recall
Haleon US Holdings LLC initiated a nationwide Class II recall (D-1323-2020) for 151,344 bottles of Gaviscon Regular Strength Liquid Antacid Cool Mint due to missing Magnesium safety warnings. This FDA-classified regulatory compliance breach underscores critical risks for procurement and regulatory teams in OTC drug labeling, demanding enhanced vigilance in quality control and supply chain oversight to prevent market disruption and reputational damage.
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