FDA recall D-0997-2020
Sunstar Guangzhou Ltd. · Class II · drug
Product
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Reason for recall
cGMP Deviation
Distribution
Florida only
Key facts
- Status
- Terminated
- Initiation date
- 2020-02-28
- Report date
- 2020-03-18
- Termination date
- 2021-03-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Guangzhou, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0997-2020