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Pink Bikini Dietary Supplement by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
AUDIENCE: Consumer
ISSUE: Lucy's Weight Loss System is voluntarily recalling all lots of Pink Bikini White powder Capsules, 30 white (750MG per capsule) to the consumer level. Pink Bikini has been found positive for diclofenac after FDA sampling and testing.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. For those that are pregnant, taking diclofenac during the last three months of pregnancy may harm the unborn baby. This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established. Lucy's Weight Loss System has not received any reports of adverse events related to this recall to date. Lucy’s Weight Loss System is notifying its customers by Press Release and is arranging for return.
BACKGROUND: Pink Bikini is marketed as a weight loss dietary supplement and is packaged in clear bottle in white powder capsules. The affected Pink Bikini and lots include the following expiration date 7/30/2017. Product was distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.
RECOMMENDATION: Consumers that have recalled Pink Bikini should stop using and discard.
Consumers with questions regarding this recall can contact Lucy's Weight Loss System by phone (682)-308-0199 or pbfitme@xxxxxxxxx on Monday thru Friday 10:00am to 5:30pm CST.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or 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.
Read the MedWatch Safety Alert, including a link to the firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm476499.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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