Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitar...
FDA Recall #D-0127-2023 — Class II — November 22, 2022
Product Description
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.
Reason for Recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
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
40,375 vials
Distribution
Nationwide in the USA
Code Information
Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated