FDA recall D-0843-2023

Akorn, Inc. · Class II · drug

Product

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), 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-0843-2023