FDA recall D-0144-2023

Akorn, Inc. · Class II · drug

Product

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

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-0144-2023