REGULATORY INTELLIGENCE·Recall
PharMEDium Services' ePHEDrine Sulfate Recall: Sterility Lapses Expose Critical Supply Chain Risks
PharMEDium Services, LLC initiated a Class II recall of 46 lots, including ePHEDrine Sulfate, due to critical sterility assurance failures. This nationwide distribution event, recall number D-1090-2020, highlights significant risks for procurement and regulatory teams relying on compounded sterile products. The termination of this recall on February 14, 2025, underscores the long-term impact of such quality lapses on patient safety and supply chain integrity.
90-Day Activity