FDA recall D-0840-2020
B AND A TRADING CORPORATION · Class II · drug
Product
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Reason for recall
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Distribution
NY & NJ only
Key facts
- Status
- Terminated
- Initiation date
- 2020-01-28
- Report date
- 2020-02-19
- Termination date
- 2023-12-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Carlstadt, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0840-2020