PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 25, 2023 Initiated: October 13, 2022 #D-0140-2023

Product Description

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:

Details

Recalling Firm
Akorn, Inc.
Units Affected
196,254 bottles
Distribution
Nationwide in the USA
Location
Gurnee, IL

Frequently Asked Questions

What product 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. Recalled by Akorn, Inc.. Units affected: 196,254 bottles.
Why was this product recalled?
CGMP Deviations:
Which agency issued this recall?
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0140-2023.