Akorn, Inc. — Class II Recall

Product

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

Reason

CGMP Deviations:

Classification

Class II

Status

Ongoing

Lot

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.

Date

2023-01-25

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.