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.

• Complete and submit the report Online:www.fda.gov/medwatch/report.htm

Topical Acne Products Can Cause Dangerous Side Effects

Certain acne treatments can, in rare instances, cause severe allergic reactions that are potentially life-threatening.

The Food and Drug Administration (FDA) is warning that the use of certain acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. An active ingredient is the component that makes the medicine effective against the illness or condition it is treating.

The acne products the FDA is warning about are sold over-the-counter (OTC) and applied to the skin (topical). Their serious allergic reactions differ from the less harmful irritations already included in the product Drug Facts labels, which include burning, dryness, itching, peeling, redness, and slight swelling where the product is applied.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, M.D., a medical officer at FDA. “It’s important that consumers know about them, and that they know what to do if they occur.”

Consumers can find out if an OTC topical acne product contains benzoyl peroxide or salicylic acid by looking at the Active Ingredient(s) section of the Drug Facts label on the product package.

FDA has issued a Drug Safety Communication (DSC) to inform both consumers and health care professionals of the potential dangers of these products.

Products of concern are marketed under different brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. They are available as gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs.

From 1969 through January 28, 2013, FDA received 131 reports from both consumers and manufacturers of allergic and hypersensitivity-related adverse reactions associated with these products. About 42% of these reactions occurred within minutes to 24 hours of use. The affected persons ranged in age from 11 to 78 years.

Types of Reactions

Forty percent of these reports described severe allergy symptoms such as throat tightness, shortness of breath, wheezing, low blood pressure, fainting or collapse. Isolated instances of hives, itching of face or body (even of parts of the body where the person did not apply the medication), and swelling of eyes, face and lips were also reported.

Based on the information reported, FDA cannot determine if these reactions were triggered by the products’ active ingredients, the inactive ingredients, or a combination of both.

While no deaths have been reported, 44% of the cases required hospitalization.

“FDA will continue to monitor closely and evaluate this safety issue,” Khurana says. The agency is also encouraging manufacturers to use the drug label to advise consumers how to test the product’s safety before using it for the first time.

For example, Khurana suggests that new users should apply a small amount of the product to a small affected area for three days. If no discomfort occurs, they can follow the labeled directions for normal use.

What to Do If a Bad Reaction Occurs

She adds that there are a number of important safety actions to counter an allergic reaction, including:

• Avoid using the product if you’ve had previous allergic or hypersensitivity reactions.
• Stop using the product if you develop hives or itching of the face or body.
• Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue; feel faint; or have difficulty breathing.

FDA encourages consumers to report any negative reactions or side effects from use of these products to the FDA’s MedWatch program.