FDAFDA · Food and drugs·Recall number 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. NDC: 17478-070-35
Published January 25, 2023 · Recall initiated: October 13, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations:
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in the USA
- Lot
- 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;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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