Drug product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
D-0150-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 163,996 bottles
- Official record key
drug-enforcement:D-0150-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot: 1L16A, 1L17A, EXP 10/31/2023; 1M29A, EXP 11/30/2023; 2A05A, EXP 12/31/2023;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations