FDA recall D-0136-2023

Product

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

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-0136-2023