Bethel Nutritional Consulting, Inc. Bethel 30: Recall: Undeclared Drug Ingredient.
ISSUE: A sample of Bethel 30 green capsule was collected and tested by FDA and found positive for Sibutramine and Phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.
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.The FDA has not approved Bethel 30, green capsules as drugs; therefore the safety and effectiveness of this product is unknown.
BACKGROUND: Bethel 30, green capsules are marketed as a Natural Herb for Weight Loss. Bethel 30 Herb Supplement is packaged in plastic white bottles containing 30 capsules per bottle and bears Lot #’s 120514, with EXP: 12/05/2014. The lot 120514 is the only one subject to recall.
RECOMMENDATION: Consumers should not consume Bethel 30, green capsules, Herb Supplement and should return it immediately to the place of purchase for a refund. Consumers with questions should contact Kariny Ramirez 212-568-5330, 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
[06/11/2013 - Firm Press Release - Bethel Nutritional Consulting, Inc.]