PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 19, 2020 Initiated: January 28, 2020 #D-0840-2020

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

Details

Units Affected
40 packages
Distribution
NY & NJ only
Location
Carlstadt, NJ

Frequently Asked Questions

What product was recalled?
Kushim Tablets (Gushim) 45-count packages, Label in foreign language. Recalled by B AND A TRADING CORPORATION. Units affected: 40 packages.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0840-2020.