D-1099-2023 Class II

Recalled by Ecometics, Inc. — Norwalk, CT

Recall Details

Product Type
Drugs
Report Date
August 30, 2023
Initiation Date
August 9, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 6,120 tubes, b) 540 tubes

Product Description

Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.

Reason for Recall

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Distribution Pattern

Nationwide in the USA

Code Information

a) and b) 1E113A, exp 4/24