FDA recall D-0146-2023

Akorn, Inc. · Class II · drug

Product

Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05

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-0146-2023