D-0840-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2020
- Initiation Date
- January 28, 2020
- Termination Date
- December 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 packages
Product Description
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 Pattern
NY & NJ only
Code Information
Lot #: H003