D-0448-2023 Class II Terminated
FDA drug recall D-0448-2023 was initiated by Ecometics, Inc. on February 24, 2023 and is designated Class II. Reason for recall: CGMP DEVIATIONS The recall status is terminated (terminated June 21, 2023). Affected quantity: 20,746 metal tubes/folding cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2023
- Initiation Date
- February 24, 2023
- Termination Date
- June 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,746 metal tubes/folding cartons
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
Reason for Recall
CGMP DEVIATIONS
Distribution Pattern
Nationwide within the United States
Code Information
Lot # 2E116A, Exp. Date APR-24