NEW ORLEANS (WVUE) - Golean Detox is voluntarily recalling all lots of Golean DETOX capsules after FDA analysis found they were tainted with sibutramine and phenolphthalein, according to the FDA.
The FDA said sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns it could be a carcinogen, is not approved for marketing in the United States.
More from the FDA:
Risk Statement: Products containing sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Health risks of ingesting phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, Golean Detox USA has not received any reports of adverse events related to this recall.
This tainted product is marketed as a dietary supplement for weight loss and is packaged in 14 packets containing 2 capsules per packet, a total of 28 capsules per box, UPC 8 938510 909013. Golean DETOX capsules were sold Nationwide in the USA to customers on Facebook at www.goleandetoxus.com.
Golean Detox USA is notifying its customers that have the Golean DETOX capsules and is arranging for return of all recalled products. Consumers that have Golean DETOX capsules should stop use and return the product.
Consumers with questions regarding this recall can contact Golean Detox USA by phone 704-537-2595 or email@example.com Monday – Thursday, EST, 4:00 pm to 6:00 pm.