Ecometics product 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 Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, O…

Recall number

D-0452-2023

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 Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756