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Smart Lipo Recall Due to Undeclared Drug Ingredients

August 10th, 2015 by

Smart Lipo Recall

What is the Smart Lipo Recall?

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Smart Lipo capsules, a product promoted for being the “best natural and herbal weight loss supplement,” due to undeclared drug ingredients. Therefore, the manufacturer, SpartLipo 365, is voluntarily recalling all lots of Smart Lipo sold at the consumer level nationwide. This product has been sold in the following stores: Centro Naturista in Richardson, Texas, SmartLipo365 in Arlington, Texas, along with national distributions via internet sales through www.SmartLipo365.com.

Products affected by the Smart Lipo recall include the following expiration dates:

  • 800mg capsules – 9/15/2017
  • 900mg capsules – 7/30/2017, and
  • 950mg capsules – 7/30/2017 & 7/30/2018

Undeclared Drugs & Smart Lipo Side Effects

Upon receiving samples of the 800 and 900mg capsules of Smart Lipo, FDA lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

Sibutramine is an appetite suppressant withdrawn from the United States market since October 2010. Sibutramine substantially increases 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, an ingredient formerly used in over-the-counter (OTC) laxatives, is not currently approved for marketing in the United States resulting from concerns of carcinogenicity, or any substance directly involved in causing cancer. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Per FDA lab results, these undeclared drug ingredients confirm the Smart Lipo recall and make this product an unapproved new drug for which safety and efficacy have not been established. In addition, combining this product with other medications you may be taking concede the possibility for life-threatening events.

Furthermore, FDA officials advise consumers to report all adverse reactions and/or quality problems experienced with the Smart Lipo recall to the FDA MedWatch Adverse Event Reporting program.

You May be at Risk. Call 1-800-380-8080 for a FREE Legal Consultation

If you or a loved one experienced adverse reactions or quality problems realted to the Smart Lipo dietary supplement, call 1-800THE-LAW2 at 1-800-380-8080 for a FREE legal consultation! Our experienced product liability, personal injury, or class action lawyers are ready to join your fight for justice resulting from an injury caused by the use of recalled products with undeclared drug ingredients like Smart Lipo. Call 1-800-3808-8080 and get connected with an attorney today. Stop suffering in silence.

 

Sources:    

  1. SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo. Retrieved June 23, 2015.
  1. Consumer Affairs. Smart Lipo Dietary Supplement Recalled. Retrieved July 7, 2015.

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Last updated September 9, 2015
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