FDA recall D-0140-2023

Product

GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12

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-0140-2023