Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of B-Lipo Capsules Due to the Presence of an Undeclared Drug Ingredient, With 0 Comments, Category: Recalls,
Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of B-Lipo Capsules Due to the Presence of an Undeclared Drug Ingredient
FOR IMMEDIATE RELEASE – December 19, 2014 – New York, NY – Bethel Nutritional Consulting, Inc. is recalling one lot ofB-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.
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.
The product was sold directly to individual customers in our New York City sales office and to consumers online atwww.bethel30.com. The company has discontinued distribution of this product.
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 [email protected], 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.
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
Bethel Nutritional Consulting, Inc. is taking this voluntary action because we are committed to the health and safety of our customers and to the quality of our select brand. We are working diligently to make available an appropriate Natural Herbal replacement product manufactured in the USA for all of our affected customers. We are moving forward with new suppliers for our NEW custom formula.
This recall is being conducted with the knowledge of the US Food and Drug Administration.
* We believe that none of the products being recalled were processed or offered through the national office.
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
For full details on the recall, please visit: http://www.fda.gov/Safety/Recalls/ucm427657.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
If you have questions, please contact Wayne Melichar, Food Safety Manager, at [email protected] or 312.629.7263.