FDA recall D-0368-2022

Akorn, Inc. · Class III · drug

Product

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

Reason for recall

Labeling: Missing Label

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2021-12-03
Report date: 2022-01-19
Termination date: 2022-08-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2022