FDA MedWatch - La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug Ingredient

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug Ingredient

AUDIENCE: 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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons.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-mailezweightlosstx@gmail.com. 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:

• 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 at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm568546.htm