Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: H003
Where it was sold
NY & NJ only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0840-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 28, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 40 packages
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B AND A TRADING CORPORATION
Original FDA data
Every field from FDA enforcement report D-0840-2020, exactly as published.
Show all FDA fields
- City
- Carlstadt
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84827
- Address
- 325 Washington Ave
- Code information
- Lot #: H003
- Postal code
- 07072-2805
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0840-2020
- Classification
- Class II
- Recalling firm
- B AND A TRADING CORPORATION
- Product quantity
- 40 packages
- Termination date
- Dec 21, 2023
- Reason for recall
- Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kushim Tablets (Gushim) 45-count packages, Label in foreign language
- Distribution pattern
- NY & NJ only
- Recall initiation date
- Jan 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 12, 2020