FDA recall D-0172-2021

Product

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-12-10

Report date

2020-12-30

Termination date

2022-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0172-2021