D-1250-2014 Class I Terminated

Recalled by Dolphin Intertrade Corporation — Miami, FL

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