Status
Ongoing
Drug Enforcement D-0149-2023
CGMP Deviations:
Classification
Class II
Report Date
January 25, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 173,928 bottles
- Reason for recall
- CGMP Deviations:
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Akorn, Inc.
- Address
-
5605 Centerpoint Ct Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0149-2023
- Event ID
- 90948
- Recall initiation date
- October 13, 2022
- Center classification date
- January 13, 2023
- Code info
- Lot: 0L48A, EXP 10/31/2022; 0L55A, EXP 10/31/2022; 1C75A, EXP 2/28/2023; 1E18A, 1E20A , EXP 4/30/2023;
- More code info
- —