Product: Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reason for recall: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Recall initiated: 20221122
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated