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Sagent Pharmaceuticals — Schaumburg

Operated by Sagent Pharmaceuticals · Schaumburg, IL
FormulationLast inspection: —
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Intelligence briefs

Regulatory Observation Log

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.

PS
Priya Subramaniam
Intelligence Analyst