February 10, 2015

Detox Transforms Health and Nutrition Recalls Dietary Supplements Due to the Presence of Undeclared Drug Ingredients

The Missouri Department of Health and Senior Services received information regarding a recall of Detox Transforms Health and Nutrition dietary supplements because they contain undeclared drug ingredients.

Product Name

Bottle Color

Label

# Capsules

UPC

Lot

Expiration

EDGE Amplified Weight Release

White

Purple label

60

852175004174

ALL

 

iNDiGO

White

Dark blue label

60

852175004044

000034

4/10/2017

AMPD Gold Bee Pollen

White

Black label

60

852175004181

ALL

 

BtRim Max

White

Dark Red label

60

852175004068

00002

4/27/2017

iNSANE Bee Pollen

White

Bright Red label

60

852175004082

0000:02

6/20/2017

FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat and cancer with long-term use.

FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended. Fluoxetine is an SSRI with potentially life-threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine-containing dietary supplement product. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine.

FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.

The products were distributed nationwide via the internet and retail stores.

The full recall can be found at: www.fda.gov/Safety/Recalls/ucm433513.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

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