Weight Loss Supplement Recalled Due to Unapproved Substances
Lucy's Weight Loss System is voluntarily recalling a dietary supplement after sampling by the U.S. Food and Drug Administration (FDA) uncovered the use of two illegal substances.
The recall applies to all lots distributed between May 25, 2015 and June 23, 2015 of Pink Bikini and Shorts on the Beach Blue and Gold Edition. The supplement tested positive for sibutramine and phenolphthalein. The presence of these substances results in a withdrawal of FDA approval, as the agency can no longer attest to the safety of the supplement.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. It 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.
Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
The product is used as a weight loss dietary supplement and is packaged in clear bottle, containing 30 blue capsules and 30 gold capsules. The affected lots list 07/30/2017 as the expiration date. The product was distributed nationwide to consumers through online orders.
Lucy's Weight Loss System has received no reports of adverse effects or complaints in relation to this product.
The manufacturer is notifying its customers by email and is arranging for return. Consumers that have recalled Pink Bikini and Shorts on the Beach should stop using the product and discard it.
Individuals with questions can contact the company at (682) 308-0199.