Lucy’s Weight Loss System is recalling all lots of Pink Bikini white powder capsules after testing revealed that the supplements contain diclofenac, a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Diclofenac can increase the risk of heart attack or stroke, especially if taken long term or in high doses.
Pink Bikini is marketed as a weight loss dietary supplement and is packaged in a clear bottle. The capsules are white powder. The affected Pink Bikini lots include the expiration date 7/30/2017 and were distributed nationwide to customers via PinkBikini.BigCartel.com and the Waisted With Lucy retail store.
The undeclared ingredient was found during routine testing of the dietary supplements by the Food and Drug Administration (FDA). “This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established,” the agency said in a Safety Alert.
Diclofenac puts people with heart disease at greater risk of adverse cardiac events, and can harm unborn babies if taken by pregnant women during the last three months of pregnancy. The drug can also cause serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
Lucy’s Weight Loss System says it has not received any reports of adverse events to date.
The FDA’s Safety Alert comes just days after the agency warned of the undisclosed drug ingredient diclofenac and the stimulant sibutramine in Lipo Escultra diet pills made by Escultra Corp. Sibutramine was the active ingredient in the anti-obesity drug Merida, which was pulled from the market because of serious heart risks.
Any side effects with these dietary supplements should be reported to the FDA MedWatch Adverse Event Program at www.FDA.gov/MedWatch/Report.htm.