Drug product
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
D-0149-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 173,928 bottles
- Official record key
drug-enforcement:D-0149-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot: 0L48A, EXP 10/31/2022; 0L55A, EXP 10/31/2022; 1C75A, EXP 2/28/2023; 1E18A, 1E20A , EXP 4/30/2023;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations