Unguentine Ointment recalled over manufacturing violations

Recall date

August 9, 2023

Source

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

Official notice title

Ecometics, Inc. recalls Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) t…

Recall number

D-1099-2023

FDA classification

Class II

Brand / firm

Ecometics, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations: Products not manufactured under current good manufacturing practices.

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 Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.