REGULATORY INTELLIGENCE·Warning Letter
Glaxosmithkline Consumer Healthcare Holdings Recalls Advil Allergy & Congestion Relief Over Critical Labeling Omissions
Glaxosmithkline Consumer Healthcare Holdings initiated a Class II recall for 471,024 blisters of Advil Allergy & Congestion Relief due to missing safety warnings on the Drug Facts Panel. This voluntary action, terminated in October 2021, underscores critical labeling compliance risks for OTC products. Procurement and regulatory teams must scrutinize supplier adherence to FDA regulations to prevent market disruptions and safeguard brand integrity.
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