Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as b...
FDA Recall #D-0129-2023 — Class II — November 22, 2022
Product Description
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), 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
31,600 vials
Distribution
Nationwide in the USA
Code Information
Batch #: 6128800, exp 12/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated