Drug 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
D-0448-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 91719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,746 metal tubes/folding cartons
- Official record key
drug-enforcement:D-0448-2023
Official wording
Reason: CGMP DEVIATIONS
Code information: Lot # 2E116A, Exp. Date APR-24
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP DEVIATIONS