D-1250-2014 Class I Terminated
FDA drug recall D-1250-2014 was initiated by Dolphin Intertrade Corporation on May 20, 2013 and is designated Class I. 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. The recall status is terminated (terminated June 29, 2016). Affected quantity: 8 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2014
- Initiation Date
- May 20, 2013
- Termination Date
- June 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
All Lots