Drug product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
D-0151-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 121,176 bottles
- Official record key
drug-enforcement:D-0151-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot: 1C61A, EXP 2/28/2023; 1D86A, 1D07A, EXP 3/31/2023;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations