January 2020 FDA Recall Drug by B And A Trading Corporation
D-0840-2020 - Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
This Class II drug recall was voluntarily initiated by B And A Trading Corporation on January 28, 2020 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. fda analysis found product to contain cinobufagin, bufalin, and bufotenine. The product was distributed in NY & NJ only and the recall is currently terminated.
Recall Number: D-0840-2020
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
01-28-2020
02-19-2020
40 packages
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
B AND A TRADING CORPORATION
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NY & NJ only
12-21-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Batch or Lot Expiration Information
Lot# : H003
