REGULATORY INTELLIGENCE·Warning Letter
Leadiant Biosciences CYSTARAN Recall: Subpotent Cysteamine HCl Exposes Ophthalmic Drug Quality Risks
Leadiant Biosciences, Inc. initiated a Class III recall for CYSTARAN (cysteamine ophthalmic solution) due to subpotent Cysteamine HCl. This event, impacting distribution in Pennsylvania and Italy, underscores critical quality control vulnerabilities in contract manufacturing. Procurement and regulatory teams must scrutinize supplier quality agreements and enhance oversight of active pharmaceutical ingredient (API) stability.
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