FDA recall D-0863-2023

Product

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Reason for recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2023-04-26

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0863-2023