FDA recall D-0289-2024
OMEZA LLC · Class II · drug
Product
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Reason for recall
CGMP Deviations
Distribution
US Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2024-01-19
- Report date
- 2024-02-14
- Termination date
- 2024-10-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Sarasota, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0289-2024