FDA recall D-0296-2016

Blue Square Market, Inc. · Class I · drug

Product

LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd

Reason for recall

Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-08-06
Report date
2015-11-25
Termination date
2018-10-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Huntingdon, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2016