FDA Recall D-1250-2014
Dolphin Intertrade Corporation · Miami, FL
Class I — life-threatening Terminated 1136 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
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.
Recall record
- Recall number
D-1250-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2013-05-20
- Classified by FDA Center
- 2014-04-18
- FDA published
- 2014-04-30
- Terminated
- 2016-06-29
- Recalling firm
- Dolphin Intertrade Corporation
- Firm location
- Miami, FL