D-0452-2023 Class II Terminated

Recalled by Ecometics, Inc. — Norwalk, CT

FDA drug recall D-0452-2023 was initiated by Ecometics, Inc. on February 24, 2023 and is designated Class II. Reason for recall: CGMP DEVIATIONS The recall status is terminated (terminated June 21, 2023).

Recall Details

Product Type
Drugs
Report Date
March 15, 2023
Initiation Date
February 24, 2023
Termination Date
June 21, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

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

Distribution Pattern

Nationwide within the United States

Code Information

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