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.
Reported: August 30, 2023 Initiated: August 9, 2023 #D-1099-2023
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.
Details
- Recalling Firm
- Ecometics, Inc.
- Units Affected
- a) 6,120 tubes, b) 540 tubes
- Distribution
- Nationwide in the USA
- Location
- Norwalk, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ecometics, Inc.. Units affected: a) 6,120 tubes, b) 540 tubes.
Why was this product recalled? ▼
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2023. Severity: Moderate. Recall number: D-1099-2023.
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