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Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a...

FDA Recall #D-1099-2023 — Class II — August 9, 2023

Recall #D-1099-2023 Date: August 9, 2023 Classification: Class II Status: Completed

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.

Recalling Firm

Ecometics, Inc. — Norwalk, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

a) 6,120 tubes, b) 540 tubes

Distribution

Nationwide in the USA

Code Information

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

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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