MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramLa Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug IngredientAUDIENCE: Consumer ISSUE: EZ Weight Loss TX is voluntarily recalling all lots of La Bri's Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in these products renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall. Sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine may also interact, in life-threatening ways with other medications a consumer may be taking. BACKGROUND: These tainted products are marketed as dietary supplements. Atomic is packaged in 60- count bottles and Xplode is packaged in 30-count bottles. All lots and codes of Atomic and Xplode are included in this recall and were sold Nationwide through internet sales starting in 2015. RECOMMENDATION: EZ Weight Loss TX is asking its customers to contact them via email or phone to arrange for a return or refund of any unused portion or replacement on these recalled products. Consumers that have these products should stop using immediately. Consumers with questions regarding this recall can contact EZ Weight Loss TX at 361-334-1977 Monday-Saturday from 11:00 am-6:30 pm CST or e-mail ezweightlosstx@xxxxxxxxx. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. 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:
Read the MedWatch safety alert at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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