FDA Drug recall D-0138-2023
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
- FDA Drug
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of 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 by Akorn, citing CGMP Deviations:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0138-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-13 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
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
CGMP Deviations:
Identifiers
| code_info | Lot: 0L58A, EXP 10/31/2022; 1B21A, 1B31A, EXP 1/31/2023; 1C44A, 1C58A, 1C58B, EXP 2/28/2023; 1E13A, 1E24A, EXP 4/30/20…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; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0138-2023%22
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