REGULATORY INTELLIGENCE·Warning Letter
Fresenius Kabi's Sensorcaine-MPF Recall: Subpotent Epinephrine Exposes Critical Quality Control Gaps
Fresenius Kabi USA, LLC initiated a Class II recall for 4411 trays of Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) due to subpotent epinephrine. This nationwide recall, D-0172-2021, highlights critical quality control failures impacting patient safety and supply chain reliability. Procurement directors must assess supplier quality systems, while regulatory affairs heads should monitor Fresenius Kabi's remediation efforts to mitigate future supply disruptions.
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