Why it was recalled
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Product description
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide
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-1250-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 20, 2013
- FDA report date
- Apr 30, 2014
- Quantity
- 8 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dolphin Intertrade Corporation
Original FDA data
Every field from FDA enforcement report D-1250-2014, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65383
- Address
- 11314 Sw 135th Ct
- Code information
- All Lots
- Postal code
- 33186-4425
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1250-2014
- Classification
- Class I
- Recalling firm
- Dolphin Intertrade Corporation
- Product quantity
- 8 bottles
- Termination date
- Jun 29, 2016
- Reason for recall
- Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
- Distribution pattern
- Nationwide
- Recall initiation date
- May 20, 2013
- Initial firm notification
- Center classification date
- Apr 18, 2014