Drug Enforcement D-1099-2023

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

Status

Completed

Classification

Class II

Report Date

August 30, 2023

Termination Date

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Product Information

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.
Product quantity
a) 6,120 tubes, b) 540 tubes
Reason for recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Ecometics, Inc.
Address
19 Concord St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1099-2023
Event ID
92857
Recall initiation date
August 9, 2023
Center classification date
August 24, 2023
Code info
a) and b) 1E113A, exp 4/24
More code info
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