Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg pe...
FDA Recall #D-0172-2021 — Class II — December 10, 2020
Product Description
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.
Reason for Recall
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4411 trays
Distribution
Nationwide in the USA
Code Information
Batch # 6123760, Exp 02/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated