Drug product
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
D-0142-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3108 bottles
- Official record key
drug-enforcement:D-0142-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot # 1F43A, EXP 5/31/2/023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations