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Recall -- Firm Press Release

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Novacare, LLC Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Salicylic Acid

Contact:
Consumer:
801-261-2252 

FOR IMMEDIATE RELEASE August 24, 2015 Murray, UT — Novacare, LLC of Murray, Utah is voluntarily recalling all lots of the following dietary supplements to the consumer level:

Name*Brand NameQuantityUPCDates of
Manufacture
Thin & SlimFataway Ultimate Stack120 capsules8530020030252/21/2011-
3/16/2011
ThermoFXThermoFX<90 capsules7935739026654/5/2011
Thin and
Slim
MaxOut Body60 capsulesN/A10/24/2011-
2/11/2014
Metabolic
Accelerator
Metabolic Accelerator120 capsules6376871145932/23/2011-
3/18/2013
Thin and
Slim
Burn Fat Now>90 capsulesN/A10/29/2011-
10/29/2014
Thin and
Slim
Thermogenic Fat Burner90 capsules02002550009510/29/2011-
10/29/2014
TruTrim Bulk 11/30/2011
Thin and
Slim Naturally AM
Thin and Slim Naturally90 capsules63768701900310/29/2011-
10/29/2014
Thin and
Slim
Extreme Stack90 capsules6376870191331/30/2012,
3/20/2012
Xcellerator Bulk 10/27/2011-
3/26/2012
Asia BlackAsia Black100 capsules8596132742295/19/2011-
5/13/2014
Black WidowBlack Widow 25100 capsules8596132522581/25/2011-
8/10/2014
MethyldreneMethyldrene Original 25100 capsules8596136384961/19/2011-
6/28/2013
* - Pictures of the product labels are included herewith for easier identification.

Sample analysis by the FDA has revealed that these products contain the undeclared drug ingredient salicylic acid making these unapproved new drugs.

Salicylic acid is acutely toxic, not recommended for oral use and is harmful if swallowed. Nausea, vomiting, gastrointestinal irritation, loss of hearing, sweating to severe reactions of blurred vision, mental confusion, cerebral edema and cardiorespiratory arrest which could be life-threatening may occur. Since the labeling does not state salicylic acid is contained it the product, individuals who are allergic, elderly, have a history of stomach ulcers or bleeding problems, consume ≥ 3 alcoholic drinks per day, or take concomitant medications containing salicylates are at higher risk for toxicity. No illnesses from these products have been reported to date.

These products are marketed as dietary supplements aiding in weight loss, produced in capsule form, and were sold in bottles. These products were distributed nationwide to distributors.

Novacare, LLC is notifying its distributors and customers by certified mail and is arranging for return of all recalled product. Consumers/distributors/retailers that have the aforementioned products that are being recalled should stop using, distributing, or selling them and return them to:

Novacare, LLC
Returns Dept.: MS# 2000
913 West 2900 South
Salt Lake City, UT 84119

Consumers with questions regarding this recall can contact Novacare, LLC directly at (801) 261-2252, Monday through Friday from 10:00 am – 4:00 pm MST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking any of the aforementioned products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug
Administration.

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Photo: Product Labels

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Page Last Updated: 08/26/2015
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