FDA recall D-1373-2014

Product

Fruta BIO 400 mg capsules, 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 active pharmaceutical ingredients: Sibutramine and Phenolphthalein .

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-1373-2014