Bethel Nutritional Consulting, Inc. Expands Voluntary Recall to Include Bethel Advance and Quick Thin Products Found to Contain an Undeclared Drug Ingredient

Date of Recall

2013-08-05

Recall Details

- August 5, 2013 - Bethel Nutritional Consulting, Inc., New York, NY, is voluntarily recalling Quick Thin and Bethel Advance to the consumer level. These products have been found to contain Sibutramine and Phenolphthalein.

Our firm was informed by the Food and Drug Administration (FDA) that samples of Quick Thin gold capsules and Bethel Advance white capsules were collected and tested by the FDA on 6/10/13. Bethel 30 green capsules were recalled by the firm on 6/11/13 for the same reason. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The FDA has not approved Bethel 30, Quick Thin, and Bethel Advance as drugs; therefore the safety and effectiveness of these products are unknown.

These products may pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking. Phenolphthalein may present health risks that could include potentially serious gastrointestinal disturbances, irregular heartbeat, muscle cramps, and cancer with long term use. No illnesses or injuries have been reported to Bethel Nutritional Consulting to date in connection with these products.

Bethel 30 green capsules, Quick Thin gold capsules, and Bethel Advance white capsules are marketed as a natural herb for weight loss.

The recalled products are packaged in plastic white bottles, 30 capsules per bottle as follows:

• Bethel 30 bears Lot # 120514 with exp. 12/05/2014 (recalled on 6/11/13);
• Bethel Advance bears Lot # 10092011 with exp. 2014;
• Quick Thin bears Lot # 10032011 with exp. 10/2014.

The products were sold directly to individual customers in our New York, NY, sales office and online at www.bethel30.com. The company has discontinued distribution and sales of these products. It sincerely regrets any inconvenience to our customers.

Consumers should not consume Bethel 30, Bethel Advance, and Quick Thin Herb Supplements and should return the products immediately to the place of purchase. Consumers with questions should contact Kariny Ramirez 212-568-5330 or via e-mail at [email protected] Monday - Friday, 10:00 am - 4:00 pm, EDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall action is being conducted with the knowledge of the FDA.

Bethel Nutritional Consulting, Inc. is taking this voluntary action because it is committed to the health and safety of its customers and to the quality of its select brands. We are working diligently to make available appropriate natural herbal replacement products manufactured in the USA for all of our affected customers. We are moving forward with new suppliers for our NEW custom formula.

We value our relationship with you and will continue to provide you with the best possible service. Thank you for your continued business and allowing us to be a trusted partner.

Previous Firm Release

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