EDGE Amplified Weight Release capsules recalled over undeclared phenolphthalein

Recall date

January 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Detox Transforms recalls EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227,…

Recall number

D-0977-2015

FDA classification

Class I

Brand / firm

Detox Transforms

Sold / distributed

WV who distributed Nationwide.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.