Drug Enforcement D-0452-2023

CGMP DEVIATIONS

Status

Terminated

Classification

Class II

Report Date

March 15, 2023

Termination Date

June 21, 2023

Product Information

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
Product quantity
—
Reason for recall
CGMP DEVIATIONS
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Ecometics, Inc.
Address
19 Concord St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0452-2023
Event ID
91719
Recall initiation date
February 24, 2023
Center classification date
March 8, 2023
Code info
Lot #: 1E346A, Exp. Date Nov-23; 2E304A, Exp. Date Oct-24
More code info
—