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.

Recall Number: D-0977-2015

Firm: Detox Transforms

Classification: Class I

Status: Terminated

Report Date: 20150513

Initiation Date: 20150125

Termination Date: 20170123

Reason for Recall

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

Product Description

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.