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Friday, August 28, 2015

13 Dietary Supplements Recalled Due to Undeclared Salicylic Acid

Novacare, LLC of Murray, Utah is voluntarily recalling all lots of the following dietary supplements to the consumer level:
Name*
Brand Name
Quantity
UPC
Dates of
Manufacture
Thin & Slim
Fataway Ultimate Stack
120 capsules
853002003025
2/21/2011-
3/16/2011
ThermoFX
ThermoFX<
90 capsules
793573902665
4/5/2011
Thin and
Slim
MaxOut Body
60 capsules
N/A
10/24/2011-
2/11/2014
Metabolic
Accelerator
Metabolic Accelerator
120 capsules
637687114593
2/23/2011-
3/18/2013
Thin and
Slim
Burn Fat Now>
90 capsules
N/A
10/29/2011-
10/29/2014
Thin and
Slim
Thermogenic Fat Burner
90 capsules
020025500095
10/29/2011-
10/29/2014
TruTrim
Bulk
11/30/2011
Thin and
Slim Naturally AM
Thin and Slim Naturally
90 capsules
637687019003
10/29/2011-
10/29/2014
Thin and
Slim
Extreme Stack
90 capsules
637687019133
1/30/2012,
3/20/2012
Xcellerator
Bulk
10/27/2011-
3/26/2012
Asia Black
Asia Black
100 capsules
859613274229
5/19/2011-
5/13/2014
Black Widow
Black Widow 25
100 capsules
859613252258
1/25/2011-
8/10/2014
Methyldrene
Methyldrene Original 25
100 capsules
859613638496
1/19/2011-
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.

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