Recalls / Class II
Class IID-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
- Affected lot / 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;
Why it was recalled
CGMP Deviations:
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5605 Centerpoint Ct Ste A, N/A, Gurnee, Illinois 60031-5278
Distribution
- Quantity
- 196,254 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-10-13
- FDA classified
- 2023-01-13
- Posted by FDA
- 2023-01-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0140-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.