Recalls / Class II
Class IID-1099-2023
Product
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.
- Affected lot / code info
- a) and b) 1E113A, exp 4/24
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recalling firm
- Firm
- Ecometics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 19 Concord St, N/A, Norwalk, Connecticut 06854-3706
Distribution
- Quantity
- a) 6,120 tubes, b) 540 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-09
- FDA classified
- 2023-08-24
- Posted by FDA
- 2023-08-30
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1099-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.