Super Fat Burner, Maxi Gold & Esmeralda Supplement Recall [US]


US FDA RecallUS/Silver Spring: FDA Logo BlueNew Life Nutritional Center recalls some Super Fat Burner, Maxi Gold and Esmeralda Dietary Supplement due to undeclared Sibutramine and Phenolphthalein, both unapproved drugs. FDA: http://ht.ly/v4ifM

Direct link: http://www.fda.gov/Safety/Recalls/ucm390608.htm

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

  • Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels, sold as weight loss aids and packaged in 30 capsule bottles. All lots of these products are being recalled.

New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA and MA via retail stores and Web sales.

According to the FDA, its analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the US market in October 2010 due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity (producing Cancer), it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time no illnesses or injuries have been reported to New Life Nutritional Center in connection with these products.

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: 3279-2014
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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