FDA-Drug2023-08-30Class II
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.
Ecometics, Inc.
Hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Sold states
Nationwide in the USA
Affected count
a) 6,120 tubes, b) 540 tubes
Manufactured in
19 Concord St, N/A, Norwalk, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1099-2023Don't want to check this manually?
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