GONAK Hypromellose Ophthalmic Demulcent Solution recalled over manufacturing violations

Recall date

October 13, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Akorn, Inc. recalls GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goino…

Recall number

D-0140-2023

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations:

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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