Drug product
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
D-0146-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65,006 bottles
- Official record key
drug-enforcement:D-0146-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations