Status
Terminated
Drug Enforcement D-0448-2023
CGMP DEVIATIONS
Classification
Class II
Report Date
March 15, 2023
Termination Date
June 21, 2023
Product Information
- Product description
- 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
- Product quantity
- 20,746 metal tubes/folding cartons
- Reason for recall
- CGMP DEVIATIONS
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Ecometics, Inc.
- Address
-
19 Concord St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0448-2023
- Event ID
- 91719
- Recall initiation date
- February 24, 2023
- Center classification date
- March 8, 2023
- Code info
- Lot # 2E116A, Exp. Date APR-24
- More code info
- —