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La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients
AUDIENCE: Consumer
ISSUE: BeeXtreme LLC is recalling all lots of La' Trim Plus, Jenesis and Oasis products from the market. Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La' Trim Plus", “Oasis”, and “Jenesis”. The recall includes all lots and expiration dates.
BACKGROUND: 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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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.
RECOMMENDATION: 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 beextremellc@xxxxxxxxx or call 814-771-4377.
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
•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.
Read the MedWatch Safety Alert, including a link to the Firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm478890.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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