Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of SLIM-K Capsules Due to Undeclared Drug Ingredients, With 0 Comments, Category: Recalls,
FOR IMMEDIATE RELEASE – December 19, 2014 – New York, NY – Bethel Nutritional Consulting, Inc. is recalling one lot ofSLIM-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. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes).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.
Products containing sibutramine pose a threat to consumers because 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.
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.
The product was sold directly to individual customers in our New York City office and online to consumers atwww.bethel30.com. The company has discontinued distribution of this product.
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 [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 or using this drug 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/ucm427662.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.