REGULATORY INTELLIGENCE·Warning Letter
Lupin Pharmaceuticals Initiates Class II Recall for Subpotent Cefixime Oral Suspension: Critical Quality Failure Impacts US Market
Lupin Pharmaceuticals Inc. initiated a Class II voluntary recall for 4,518 bottles of Cefixime for Oral Suspension USP due to subpotency. This event, stemming from a stability study failure, highlights critical quality control vulnerabilities. Procurement, regulatory, and supply chain leaders must reassess supplier qualification and risk mitigation strategies to prevent similar disruptions and ensure patient safety.
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