FDA recall D-0980-2015

Detox Transforms · Class I · drug

Product

BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.

Reason for recall

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.

Distribution

WV who distributed Nationwide.

Key facts

Status
Terminated
Initiation date
2015-01-25
Report date
2015-05-13
Termination date
2017-01-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Garner, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0980-2015