FDA recall D-1372-2014

MyNicNaxs, Inc. · Class I · drug

Product

JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL

Reason for recall

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-01-24
Report date
2014-06-18
Termination date
2019-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deltona, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1372-2014