REGULATORY INTELLIGENCE·Warning Letter
FDA Regulatory Action: Church & Dwight's Zicam Elderberry Drops Recalled Over Labeling Non-Compliance
Church & Dwight Co., Inc. faces FDA regulatory action, initiating a Class II recall for 21,912 bottles of Zicam Cold Remedy Medicated Fruit Drops - Elderberry due to undeclared elderberry. This significant enforcement highlights critical compliance gaps in OTC drug labeling, posing substantial supply chain and regulatory risks for global chemical and life sciences firms. Procurement and regulatory teams must scrutinize ingredient declarations rigorously.
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