FDA-Drug2020-12-30Class II
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.
Fresenius Kabi USA, LLC
Hazard
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Sold states
Nationwide in the USA
Affected count
4411 trays
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0172-2021Don't want to check this manually?
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