FDA recall D-0815-2023

Akorn, Inc. · Class II · drug

Product

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. 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-0815-2023