Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg p
Recalled January 25, 2023 · FDA recall D-0127-2023 · Fresenius Kabi USA
Hazard
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. · FDA Class II
Units
40,375 vials
Sold at
Nationwide in the USA
Description
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Product
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), 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 →