Recalled Dietary Supplements Have Undeclared Drug Ingredients that Could be Dangerous, FDA Warns

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Recalled Supplements Have Undeclared Drug Ingredients
Recalled Supplements Have Undeclared Drug Ingredients

Recalled Supplements Have Undeclared Drug Ingredients
Recalled Supplements Have Undeclared Drug Ingredients

Lucy’s Weight Loss System has issued a voluntary recall of all lots of Pink Bikini and Shorts on the Beach Blue and Gold Edition dietary capsules distributed from May 25 – June 23, 2015.

Food and Drug Administration (FDA) testing of random samples of Pink Bikini and Shorts on the Beach showed the capsules contained the unapproved drug ingredients sibutramine and phenolphthalein.

Sibutramine, an appetite suppressant, was withdrawn from the U.S. market in October 2010. Sibutramine substantially increases blood pressure and/or pulse rate in some people and it may pose a significant health risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke, according to the FDA. Phenolphthalein used to be an ingredient in over-the-counter laxatives, but because of concerns over carcinogenicity, it is not currently approved for use in the United States. The health risks associated with phenolphthalein include serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

By FDA standards, 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 cause life-threatening interactions with other medications the consumer may be taking. The FDA warns of an “emerging trend” in which where over-the-counter products—often dietary supplements—contain hidden active ingredients that could be harmful to the user. The consumer will not know the quantity or purity of the prescription drug ingredients, or what controlled substances, and untested and unstudied pharmaceutically active ingredients are in a supplement. “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 weight loss dietary supplement, packaged in clear bottles labeled in pink, blue and gold. The recalled Pink Bikini and Shorts on the Beach lots have the expiration date 7/30/2017. Both supplements were sold online nationwide.

The company says that, to date, it has not received any complaints about the products or reports of adverse events related to the recall. Lucy’s Weight Loss System is notifying its customers by email and will arrange for return of the products. But the company advises consumers who have any of the recalled Pink Bikini and Shorts on the Beach to stop using the supplement and discard remaining capsules.

Consumers with questions about this recall should contact Lucy’s Weight Loss System by phone (682)-308-0199 or at pbfitme@gmail.com on Monday thru Friday 10:00am to 5:30pm CST. Consumers should contact a doctor or a health care provider if they have experienced any problems that may be related to the use of this drug product.

The FDA encourages consumers to report adverse reactions or quality problems with these products through the MedWatch Adverse Event Reporting program online (www.fda.gov/medwatch/report.htm), by 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.