Fresenius Kabi USA LLC recalls Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL),
Recalled July 14, 2021 · FDA recall D-0651-2021 · Fresenius Kabi USA
Hazard
Low out of specification results for epinephrine assay. · FDA Class II
Units
234,800 vials
Sold at
Distributed Nationwide in the USA
Description
Low out of specification results for epinephrine assay.
Product
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Manufacturer(s)
Fresenius Kabi USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →