Fresenius Kabi USA, LLC recalls Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dos
Recalled December 30, 2020 · FDA recall D-0172-2021 · Fresenius Kabi USA
Hazard
Subpotent Drug: Low out-of-specification assay results for the epinephrine component. · FDA Class II
Units
4411 trays
Sold at
Nationwide in the USA
Description
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
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.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →