Recall -- Firm Press Release
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Novacare, LLC Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Salicylic Acid
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 Name||Quantity||UPC||Dates of|
|Thin & Slim||Fataway Ultimate Stack||120 capsules||853002003025||2/21/2011-|
|MaxOut Body||60 capsules||N/A||10/24/2011-|
|Metabolic Accelerator||120 capsules||637687114593||2/23/2011-|
|Burn Fat Now>||90 capsules||N/A||10/29/2011-|
|Thermogenic Fat Burner||90 capsules||020025500095||10/29/2011-|
Slim Naturally AM
|Thin and Slim Naturally||90 capsules||637687019003||10/29/2011-|
|Extreme Stack||90 capsules||637687019133||1/30/2012,|
|Asia Black||Asia Black||100 capsules||859613274229||5/19/2011-|
|Black Widow||Black Widow 25||100 capsules||859613252258||1/25/2011-|
|Methyldrene||Methyldrene Original 25||100 capsules||859613638496||1/19/2011-|
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:
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.
- Complete and submit the report Online:www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug
Photo: Product Labels
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.