FDA recall D-0977-2015

Product

EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.

Reason for recall

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE 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-0977-2015