PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 15, 2023 Initiated: February 24, 2023 #D-0448-2023

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

Details

Recalling Firm
Ecometics, Inc.
Units Affected
20,746 metal tubes/folding cartons
Distribution
Nationwide within the United States
Location
Norwalk, CT

Frequently Asked Questions

What product 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. Recalled by Ecometics, Inc.. Units affected: 20,746 metal tubes/folding cartons.
Why was this product recalled?
CGMP DEVIATIONS
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2023. Severity: Moderate. Recall number: D-0448-2023.