FDA recall D-1250-2014

Dolphin Intertrade Corporation · Class I · drug

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-20
Report date: 2014-04-30
Termination date: 2016-06-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1250-2014