Class II
Completed
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.
This recall has been completed (originally issued August 30, 2023).
- Company
- Ecometics, Inc.
- Recall Initiated
- August 9, 2023
- Posted
- August 30, 2023
- Recall Number
- D-1099-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 6,120 tubes, b) 540 tubes
- Firm Location
- Norwalk, CT, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Distribution
Nationwide in the USA
Lot / Code Info
a) and b) 1E113A, exp 4/24
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