FDA recall D-1375-2014

Product

Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 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 ingredient: 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-1375-2014