Smart Lipo365 Dietary Supplement Recall [US]


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US/Silver Spring: Smart Lipo365 recalls all lots of Smart Lipo 800, 900, 950 mg capsules due undeclared sibutramine, desmethylsibutramine and phenolphthalein, all restricted and/or withdrawn drugs. FDA: http://ht.ly/W7nHM

Direct link: http://www.fda.gov/Safety/Recalls/ucm478146.htm

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

  • Smart Lipo, marketed as a dietary supplement and packaged in bottles of 30 capsules in 800 mg, 900 mg and 950 mg per capsule. The affected Smart Lipo products include all expiration dates.

Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet from http://www.SmartLipo365.com.

According to the FDA, Sibutramine is an appetite suppressant that was withdrawn from the US market in October 2010.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.

Phenolphthalein 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 United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat and Cancer with long-term use.

These undeclared ingredients make these Dietary Supplements unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

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

If you have any questions about this recall, please contact SmartLipo365 at 1-972-757-8136 10:00 AM to 5:00 PM Central Time or on the Web at http://www.SmartLipo365.com.

Please note: similar Dietary Supplements from this manufacturer have been recalled previously. To see all notifications related to this product, please search for “Smart Lipo” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Dietary Supplements, please search for “supplements” 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: 6230-2015
More recalls? Back to the main Recalls Direct page: http://www.RecallsDirect.com/
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Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

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