D-0138-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 25, 2023
- Initiation Date
- October 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,109,600 tubes
Product Description
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
Reason for Recall
CGMP Deviations:
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 0L58A, EXP 10/31/2022; 1B21A, 1B31A, EXP 1/31/2023; 1C44A, 1C58A, 1C58B, EXP 2/28/2023; 1E13A, 1E24A, EXP 4/30/2023; 1C57A, EXP 2/28/2023; 1G60A, 1G62A, 1G63A, EXP 6/30/2023; 1J34B, 1J40A, 1J21A, EXP 8/31/2023; 1K74A, EXP 9/30/2023; 1L93A, 1L96B, 1L96A, EXP 10/31/2023; 1M25A, 1M24A, 1M31A, EXP 11/30/2023; 2A02A, 2A10A, EXP 12/31/2023; 2C07A, EXP 2/29/2024; 2D47A, EXP 3/31/2024; 2E50A, 2E51A, EXP 4/30/2024;