Lucy’s Weight Loss Dietary Supplement Recall [US]


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US/Silver Spring: Lucy’s Weight Loss System recalls all lots of Pink Bikini Dietary Supplements and Shorts on the Beach Dietary Supplements due to undeclared Sibutramine, Phenolphthalein, and/or Diclofenac, all restricted, controlled or withdrawn drugs capable of serious injury, Cancer and/or death. FDA: http://ht.ly/XLIeh

Direct link: http://www.fda.gov/Safety/Recalls/ucm483928.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:

  • Pink Bikini Dietary Supplements, sold in bottles of 30 capsules with an expiration date of 7/30/2017
  • Shorts on the Beach Dietary Supplements, sold in bottles of 30 capsules with an expiration date of expiration date 7/30/2017

According to the FDA, the Dietary Supplements are marketed as a weight loss dietary supplement and is packaged in clear bottle in multiple color capsules and were distributed US nationwide to consumers via http://www.PinkBikini.BigCartel.com and Waisted With Lucy Retail store.

  • Sibutramine is an appetite suppressant that was withdrawn from the US market in October 2010.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.
  • 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 US Health risks associated with Phenophthalein 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 people already taking NSAIDS, with allergies, with underlying illnesses or with recent Cardiac Bypass Surgery, could lead to gastrointestinal disturbances, fatal Heart Attack or Stroke.

Lucy’s Weight Loss System is recommending that Pink Bikini and Shorts on the Beach, in all strengths and pill colors not be consumed, as they may contain any of the above undeclared active pharmaceutical ingredients and/or an unknown active pharmaceutical ingredient. Any of these undeclared ingredients would make this product an unapproved new drug for which safety and efficacy have not been established.

If you believe you have purchased or have in your possession any of the recalled Dietary Supplements, please do not consume them. Instead, kindly return the product to the store where you purchased it for a full refund.

If you have any questions about this recall, please contact Lucy’s Weight Loss System by phone 1-682-308-0199 from 10:00 AM to 5:30 PM Central Standard Time or e-mail at PBFITME@gmail.com.

==> To see other recalls and notifications relating to Dietary Supplements, please search for “supplements” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Sibutramine contamination, please search for “Sibutramine” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Phenophthalein contamination, please search for “Phenophthalein” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Diclofenac contamination, please search for “Diclofenac” using the Search Box at the top of this page.

Want to read more about this recall? Please click on the links above to visit the originating site.

Want to read more about other recalls? Please click on the links below.

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Additional information about this recall:
Recalls Direct RIN: 6444-2016
More recalls? Back to the main Recalls Direct page: http://www.RecallsDirect.com/
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

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