Unguentine Original Ointment for Burns packaged in metal tubes recalled over manufacturing violations

Recall date

February 24, 2023

Source

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

Official notice title

Ecometics, Inc. recalls Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g…

Recall number

D-0448-2023

FDA classification

Class II

Brand / firm

Ecometics, Inc.

Sold / distributed

Nationwide within the United States

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

Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756