Drug product
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
D-0155-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 524,506 tubes
- Official record key
drug-enforcement:D-0155-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot: 0F69A, EXP 5/31/2023; 0G92B, 0G92A, EXP 6/30/2023; 0J69A, EXP 8/31/2023; 0K29A, 0K24A, EXP 9/30/2023; 0M93A, 0M92A, 0M92B, EXP 11/30/2023; 1B25A, EXP 1/31/2024; 1C74A, EXP 2/29/2024; 1E19A, EXP 4/30/2024; 1C77A, EXP 2/29/2024;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations