SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients

[Posted 12/22/2014]

AUDIENCE: Consumer

ISSUE: Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of SLIM-K collected and tested by the FDA was found to contain sibutramine, desmethylsibutramine, and phenolphthalein. Products containing sibutramine pose a threat to consumers besause sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

No illnesses or injuries have been reported to the company to date in connection with this product.

BACKGROUND: Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established.

SLIM-K Capsules are marketed as a Natural Herbal Supplement for Weight Loss. SLIM-K blue and white capsules are packaged in white plastic bottles containing 30 Capsules per bottle, and labeled with Lot # 140430, Expiration 12/2017, and barcode 160126417509.

RECOMMENDATION: Consumers should not consume SLIM-K Capsules and should return it immediately to the place of purchase. Consumers with questions should contact Kariny Ramirez by phone at (212) 568-5330 or via e-mail at customerservice@bethel30.com, Monday - Friday, 11:00 am - 4:00 pm, ET. 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

[12/19/2014 - Firm Press Release - FDA]