FDA recall D-0128-2023

Product

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), 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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-11-22

Report date

2023-01-25

Termination date

2023-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0128-2023