Status
Ongoing
Drug Enforcement D-0139-2023
CGMP Deviations:
Classification
Class II
Report Date
January 25, 2023
Termination Date
—
Product Information
- Product description
- Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
- Product quantity
- 36,455 cartons
- 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-0139-2023
- Event ID
- 90948
- Recall initiation date
- October 13, 2022
- Center classification date
- January 13, 2023
- Code info
- Lot: 1B14B, EXP 1/31/2023; 1C49A, 1C49B, 1C70A, EXP 2/28/2023; 1E09A, 1E34A, 1E34B, 1E09B, EXP 4/30/2023; 1F37C, 1F37A, 1F37B, EXP 5/31/2023; 1G58A, 1G57B, 1G58B, 1G66B, 1G66A, 1G57A, EXP 6/30/2023; 1H77B, 1H80A, 1H80B, 1H77A, EXP 7/31/2023; 1J24A, EXP 8/31/2023; 1K67B, 1K67A, 1K76A, 1K87B, 1K77A, 1K76B, 1K87A, 1K77B, EXP 9/30/2023; 1L90B, 1L90A, 1L92B, 1L92A, EXP 10/31/2023; 1M28A, 1M35A, 1M28B, EXP 11/30/2023; 2D20B, EXP 3/31/2024.
- More code info
- —