AUDIENCE: Consumer, Patient, Health Professional
ISSUE: 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, and may pose a threat to consumers. 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.
BACKGROUND: 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. The firm was informed by 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.
Bethel 30 green capsules, Quick Thin gold capsules, and Bethel Advance white capsules are marketed as a natural herb for weight loss. Bethel 30 bears Lot # 120514 with exp. 12/05/2014 (recalled on 6/11/13), Bethel Advance bears Lot # 10092011 with exp. 2014, and Quick Thin bears Lot # 10032011 with exp. 10/2014.
RECOMMENDATION: 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@example.com 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form 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
[08/05/2013 - Firm Press Release - Bethel Nutritional Consulting, Inc.]
Previous MedWatch Alert:
[06/11/2013 - MedWatch Safety Alert - FDA]