Akorn, Inc. — Class II Recall

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

CGMP Deviations:

Classification

Class II

Status

Ongoing

Lot

Lot: 0C80A, EXP 2/28/2023; 0B71A, 1B32A, EXP 1/31/2023; 0C80B, EXP 2/28/2023; 0F68A, EXP 5/31/2023; 0G85A, 0G01A, 1G54A, 1G71A, EXP 6/30/2023; 0H32A, 0H47A, 1H75A, EXP 7/31/2023; 0K22A, EXP 9/30/2023; 0M90A, EXP 11/30/2023;

Date

2023-01-25

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.