Status
Ongoing
Drug Enforcement D-0150-2023
CGMP Deviations:
Classification
Class II
Report Date
January 25, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 163,996 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-0150-2023
- Event ID
- 90948
- Recall initiation date
- October 13, 2022
- Center classification date
- January 13, 2023
- Code info
- Lot: 1L16A, 1L17A, EXP 10/31/2023; 1M29A, EXP 11/30/2023; 2A05A, EXP 12/31/2023;
- More code info
- —