FDA recall D-0153-2023

Akorn, Inc. · Class II · drug

Product

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

Reason for recall

CGMP Deviations:

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2022-10-13
Report date: 2023-01-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2023