REGULATORY INTELLIGENCERecall22d ago
Sagent Pharmaceuticals Recalls Busulfan Injection Over Impurity Failures, Raising Supply Chain Concerns
Sagent Pharmaceuticals has initiated a Class III recall of 9,528 vials of Busulfan Injection (NDC 25021-241-10) nationwide due to failed impurities and degradation specifications. This marks Sagent's second significant recall in two years, following a 2024 event for Methylprednisolone Acetate. Procurement and regulatory teams must assess supply chain stability for Busulfan, an oncology drug, and evaluate alternative suppliers to mitigate potential disruptions.
Sagent PharmaceuticalsWater For InjectionSagent Pharmaceuticals — Schaumburg · SchaumburgHSN 29350090
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Priya Subramaniam
Intelligence Analyst