The Recall Desk
SevereFDA (Drugs)·D-0840-2020·Announced 2020-02-19

Kushim Tablets Recalled for Unapproved Active Ingredients

B and A Trading Corporation is recalling 40 packages of Kushim Tablets marketed without FDA approval. Analysis found the product contains unapproved active ingredients.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The presence of unapproved active ingredients in a drug product represents a significant health risk.

Plain-English summary

B and A Trading Corporation is recalling 40 packages of Kushim Tablets (Gushim) 45-count packages. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall is limited to New York and New Jersey, with lot number H003.

The FDA conducted an analysis of the product and found it contains cinobufagin, bufalin, and bufotenine. These ingredients were not listed on the product label, which was in a foreign language. The presence of these unapproved active ingredients poses a potential health risk to consumers.

Consumers who purchased these specific packages should stop using the product and contact the recalling firm for instructions on how to return or dispose of it. The recall is voluntary and initiated by the manufacturer in response to the FDA's findings.

The recalled product

Product
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Manufacturer
B AND A TRADING CORPORATION
Category
Drug — Unapproved Drug
Hazard
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #: H003

Distribution

Distributed in 2 states:

Related recalls

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