FDA recall D-0651-2021

Product

Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37

Reason for recall

Low out of specification results for epinephrine assay.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-06-25

Report date

2021-07-14

Termination date

2022-12-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melrose Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2021