FDA recall D-0852-2023

Akorn, Inc. · Class II · drug

Product

Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- 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-0852-2023