Urgent: Drug Recall – Weight Loss Dietary Supplements with Undeclared Sibutramine and Phenolphthalein

Urgent: Drug Recall – Weight Loss Dietary Supplements with Undeclared Sibutramine and Phenolphthalein

Posted by Lara Wheeler, With 0 Comments, Category: Recalls, Tags: , ,

Urgent: Drug Recall – Weight Loss Dietary Supplements with Undeclared Sibutramine and Phenolphthalein
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

For Immediate Release
December 23, 2015
Toni Sweeney
[email protected]

Firm Press Release
Under the brands: La’ Trim Plus, Jenesis and Oasis, all lots and expiration dates.
Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement “La’Trim Plus”, “Oasis”, and “Jenesis”. As a Seller of these products, my customer’s health is my first priority, therefore BeeXtreme LLC is recalling all lots of La’ Trim Plus, Jenesis and Oasis products from the market.
Sibutramine and Phenolphthalein pose a significant health hazard. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. It 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. 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. Health risks associated with phenolphthalein could include potentially serious, gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Please determine if you have any of the above products on hand. If so, please discontinue selling the products and do not consume them. Please promptly dispose of all identified products.
If you have further distributed La’ Trim, Jenesis and/or Oasis, please contact your customers if possible and advise them of the recall situation. Provide them with a copy of this notice. Have them return their outstanding recalled stocks to you. If you have any questions regarding this recall please contact me at [email protected] or 814-771-4377.

*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/ucm478883.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.