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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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