Erythromycin Ophthalmic Ointment USP recalled over manufacturing violations

Recall date

October 13, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Akorn, Inc. recalls Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufact…

Recall number

D-0139-2023

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations:

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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