Status
Ongoing
Drug Enforcement D-0140-2023
CGMP Deviations:
Classification
Class II
Report Date
January 25, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 196,254 bottles
- Reason for recall
- CGMP Deviations:
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Akorn, Inc.
- Address
-
5605 Centerpoint Ct Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0140-2023
- Event ID
- 90948
- Recall initiation date
- October 13, 2022
- Center classification date
- January 13, 2023
- Code info
- 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;
- More code info
- —