- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionMislabeling
- Company Name:
- Envy Me
- Brand Name:
Brand Name(s)LaBri’s Body Health
- Product Description:
Product DescriptionDietary Supplement
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 United States Food and Drug Administration has 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.
The recall is being conducted to the consumer level. The products were sold nationwide through internet sale and we began shipping this product in early 2015. 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. Envy Me has not received any reports of illnesses to date but the FDA reports one adverse event reported in June 2016.
Please contact our office at 361-658-0241 or email me at firstname.lastname@example.org for refund details. We can either refund your money or replace the product with a comparable product upon return of the 60 capsule bottle of LaBri’s Body Health Atomic.
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. Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
This recall is being made with the knowledge of the Food and Drug Administration.