Lucy's Weight Loss System Issues Recalls for Two Weight Loss Supplements
Lucy's Weight Loss System is voluntarily recalling supplements due to hidden and unapproved medications.
The company is recalling all colors of Pink Bikini and Shorts on the Beach Capsules. Analysis conducted by the Food and Drug Administration (FDA) reveals that the supplements contain sibutramine, phenolphthalein, and diclofenac, and that these active ingredients are not declared on the label.
Any of these ingredients would make this product an unapproved new drug for which safety and efficacy have not been established.
The product is marketed as a weight loss dietary supplement and is packaged in clear, 30-count bottle in multiple color capsules. Pink Bikini is sold in white, blue, and gold capsules, while Shorts on the Beach is blue or gold. The affected Pink Bikini and Shorts on the Beach lots include the expiration date 07/30/2017.
These products were distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. The substance is known to substantially increase blood pressure and 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.
Phenophthalein 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 U.S. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Use of diclofenac in patients already taking NSAIDS, with allergies, with underlying illnesses or with recent cardiac bypass surgery, could lead to gastrointestinal disturbances, fatal heart attack or stroke.
Consumers are advised to stop using and discard the recalled supplements.
Customers with questions about this recall can contact the company by phone at (682) 308-0199 or by email at PBFITME@gmail.com.