Recalls / Class II
Class IID-0448-2023
Product
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
- Affected lot / code info
- Lot # 2E116A, Exp. Date APR-24
Why it was recalled
CGMP DEVIATIONS
Recalling firm
- Firm
- Ecometics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 19 Concord St, Norwalk, Connecticut 06854-3706
Distribution
- Quantity
- 20,746 metal tubes/folding cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-02-24
- FDA classified
- 2023-03-08
- Posted by FDA
- 2023-03-15
- Terminated
- 2023-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0448-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.