Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) ...
FDA Recall #D-0448-2023 — Class II — February 24, 2023
Product Description
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
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
Product Quantity
20,746 metal tubes/folding cartons
Distribution
Nationwide within the United States
Code Information
Lot # 2E116A, Exp. Date APR-24
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated