Product: Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reason for recall: Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Recall initiated: 20201210
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated