RecallDepth
Class II Terminated

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.

Company
Fresenius Kabi Usa, Llc
Recall Initiated
December 10, 2020
Posted
December 30, 2020
Recall Number
D-0172-2021
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
4411 trays
Firm Location
Lake Zurich, IL, United States

Reason for Recall

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Distribution

Nationwide in the USA

Lot / Code Info

Batch # 6123760, Exp 02/2022

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