Lucy’s Weight Loss System is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Blue and Gold Edition capsules distributed from May 25 – June 23, 2015.
Samples of Pink Bikini and Shorts on the Beach tested found positive for the substances sibutramine and phenolphthalein in random Food and Drug Administration (FDA) testing.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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, according to the FDA. Phenolphthalein was previously an ingredient in over-the-counter laxatives, but because of concerns over carcinogenicity, it is not currently approved for use in the United States. Health risks associated with phenolphthalein include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
These undeclared ingredients make the Lucy’s Weight Loss System products unapproved new drugs for which safety and efficacy have not been established. The FDA warns that the products may also interact in life-threatening ways with other medications a consumer may be taking. The agency says it has identified an emerging trend where over-the-counter products—frequently dietary supplements—contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with unspecified quantities of prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. “Hidden ingredients are increasingly becoming a problem in products promoted for weight loss,” according to the FDA.
Pink Bikini and Shorts on the Beach products are used as a weight loss dietary supplement and are packaged in clear bottles labeled in pink, blue and gold. The affected Pink Bikini and Shorts on the Beach lots have the expiration date 7/30/2017. The supplements were distributed nationwide via Internet.
To date, Lucy’s Weight Loss System has not received not received any complaints or any reports of adverse events related to this recall. Lucy’s Weight Loss System is notifying its customers by email and is arranging for return of the products. Consumers who have recalled Pink Bikini and Shorts on the Beach should stop using and discard remaining capsules.
Consumers with questions about this recall can contact Lucy’s Weight Loss System by phone (682)-308-0199 or firstname.lastname@example.org on Monday thru Friday 10:00am to 5:30pm CST. Consumers should contact their physician or a health care provider if they have experienced any problems that may be related to the use of this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online (www.fda.gov/medwatch/report.htm), by regular mail or by fax. Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.