[Posted 03/30/2017]
AUDIENCE: Consumer
ISSUE: Envy Me is recalling LaBri’s Body Health Atomic, dietary supplement marketed for weight loss, sold in 60 capsule, plastic bottles. The recall includes all lot codes, manufacturing codes and expiration dates.
The FDA analyzed samples of La Bri’s Body Health Atomic and found it to contain the undeclared ingredient sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine 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. Sibutramine may also interact in life-threatening ways with other medications a consumer may be taking.
BACKGROUND: The recall is being conducted to the consumer level. The products were sold nationwide through internet sales.
RECOMMENDATION: Consumers should stop using the product immediately and throw it away in accordance with your state and local ordinances for drug products or return the unused portion of product for a refund or replacement. 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
[03/30/2017 - Press Release - Envy Me]
