FDA recall Z-0720-2022
Sunstar Americas, Inc. · Class II · device
Product
BUTLER Clear Dip, 12 bottles/case
Reason for recall
Product lacks premarket clearance.
Distribution
United States Nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-14
- Report date
- 2022-03-09
- Termination date
- 2023-08-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Schaumburg, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2022