D-1099-2023 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- August 30, 2023
- Initiation Date
- August 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 6,120 tubes, b) 540 tubes
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.
Distribution Pattern
Nationwide in the USA
Code Information
a) and b) 1E113A, exp 4/24