REGULATORY INTELLIGENCE·Warning Letter
Azurity Pharmaceuticals' Class I Dextroamphetamine Sulfate Recall Highlights Critical Labeling Risks
Azurity Pharmaceuticals initiated a Class I recall for 4,662 bottles of Zenzedi (Dextroamphetamine Sulfate) CII Tablets due to a labeling mix-up. This high-severity event, now terminated, underscores critical quality control deficiencies in pharmaceutical packaging. Procurement, regulatory, and supply chain leaders must enhance due diligence on contract manufacturers and internal labeling processes to mitigate similar risks with controlled substances.
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