B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient

[Posted 12/22/2014]

AUDIENCE: Consumer

ISSUE: Bethel Nutritional Consulting, Inc. is recalling one lot of B-Lipo Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of B-Lipo Capsules collected and tested by the FDA was found to contain lorcaserin, a controlled substance used for weight loss. Adverse health consequences associated with taking lorcaserin range from difficulty thinking, hallucinations, and feeling of intense excitement to changes in blood sugar and heart rate. More serious adverse events, which may be life-threatening, include damage to the heart valve, or serotonin syndrome particularly if Lipo-B is taken with other medications that work similarly. Excessive levels of serotonin can cause symptoms that range from mild (shivering and diarrhea) to severe (muscle stiffness, fever, and seizures). Severe serotonin syndrome can be fatal if not treated. No illnesses or injuries have been reported to the company to date in connection with this product.

BACKGROUND:  B-Lipo Capsules are marketed as a Natural Herbal Supplement for Weight Loss. B-Lipo burgundy and white Capsules are packaged in white plastic bottles containing 30 Capsules per bottle, and labeled with Lot #20213 EXP DATE 12/22/2016, and bar code 160126 417509.

RECOMMENDATION: Consumers should not consume B-Lipo 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 this 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]