FDA recall D-0149-2023

Product

Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12

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-0149-2023