Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5...

FDA Recall #D-0452-2023 — Class II — February 24, 2023

Recall #D-0452-2023 Date: February 24, 2023 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

CGMP DEVIATIONS

Recalling Firm

Ecometics, Inc. — Norwalk, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

Nationwide within the United States

Code Information

Lot #: 1E346A, Exp. Date Nov-23; 2E304A, Exp. Date Oct-24

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated