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Detox Transforms Health and Nutrition announced a voluntary recall of five dietary supplements after they were found to contain undeclared drug ingredients:
- EDGE Amplified Weight Release: All lots
- iNDiGO: Lot #000034, Expiration date 4/10/2017
- AMPD Gold Bee Pollen: All lots
- BtRim Max: Lot #00002, Expiration date 4/27/2017
- iNSANE Bee Pollen: Lot #0000:02, Expiration date 6/20/2017
iNDiGO and BtRim Max were found to contain undeclared phenolphthalein through a Food and Drug Administration (FDA) analysis. Phenolphthalein is a chemical is not an approved ingredient in the United States. Adverse reactions can include potentially serious GI disturbances, irregular heartbeat, and cancer with long-term use.
RELATED: Store-Brand Herbal Supplements Under Scrutiny
EDGE Amplified Weight Release and iNSANE Bee Pollen were found to contain undeclared phenolphthalein and fluoxetine. Concomitant use of fluoxetine with other drugs such as MAO inhibitors and serotonin precursors (eg, tryptophans) is either contraindicated or not recommended. Use of fluoxetine, a selective serotonin reuptake inhibitor (SSRI), can lead to suicidal thinking, abnormal bleeding, and seizures.
AMPD Gold Bee Pollen was found to contain undeclared sildenafil. Sildenafil is a phosphodiesterase type 5 inhibitor that can place males at risk of life-threatening hypotensive events. Concomitant medications such as ritonavir, ketoconazole, itraconazole, and substantial alcohol consumption can also increase the effects sildenafil.
These dietary supplements have been distributed nationwide through the internet and retail stores. Detox Transforms has stopped product distribution and is notifying customers to arrange for return of all affected products.
For more information call (877) 404-7873 or visit FDA.gov.
