Kushim Tablets (Gushim) 45-count packages, Label in foreign language

Recall Number: D-0840-2020

Firm: B AND A TRADING CORPORATION

Classification: Class II

Status: Terminated

Report Date: 20200219

Initiation Date: 20200128

Termination Date: 20231221

Reason for Recall

Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine

Product Description

Kushim Tablets (Gushim) 45-count packages, Label in foreign language