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Products found to contain undeclared medicines

The United States: Detox Transforms Health and Nutrition issues voluntary nationwide recall of dietary supplements - Signature Skinny EDGE Amplified Weight Release, AMPD Gold, iNSANE, iNDiGO and BtRim - due to the presence of undeclared drug ingredients
Detox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.

- Signature Skinny EDGE Amplified Weight Release and iNSANE Bee Pollen: contain phenolphthalein and fluoxetine;
- iNDiGO and BtRim Max: contain phenolphthalein; and
- AMPD Gold Bee Pollen: contains sildenafil

Phenolphthalein could potentiallly lead to serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. 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. 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. No illnesses have been reported to date with the use of these products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.

Please refer to the following website in FDA for details:

In Hong Kong, the above products are not registered pharmaceutical products.

Ends/ Tuesday, February 10, 2015
Issued at HKT 13:00