Drug product
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
D-0840-2020
Product summary
- Event
- Event 84827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 packages
- Official record key
drug-enforcement:D-0840-2020
Official wording
Reason: Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Code information: Lot #: H003
Distribution pattern: NY & NJ only
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine