Drug 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.

D-0977-2015

January 25, 2015

Class I

Product summary

Firm: Detox Transforms
Event: Event 70444
Status: Terminated
Classification: Class I
Quantity: 150 bottles
Official record key: drug-enforcement:D-0977-2015

Official wording

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

Code information: Lots: ALL

Distribution pattern: WV who distributed Nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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