Esbelin Silouttte Te and Esbelin Siloutte Vitamin Supplement: Recall - Undeclared Drug Ingredients
ISSUE: On July 19, 2013, Herbal Give Care LLC issued a voluntarily recall of all lots of Esbelin siloutte te and Esbelin siloutte Herbal Blend with L-Carnitine (30 Capsules), to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. These products may pose 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.
BACKGROUND: The Esbelin siloutte Herbal Blend with L-Carnitine (30 capsules) product is used to help normalize nervous appetite, preventing fat accumulation and fluid retention in tissues. The Esbelin siloutte Herbal Blend with L-Carnitine (30 Capsules) is packaged in a white plastic bottle with a screw cap containing 30 capsules per bottle.
Esbelin siloutte Te is a product used as a fat burner, as it removes the fat stored in the body, thereby achieving elimination of the fat through the urine and preventing its accumulation. The product is also intended to promote the proper functioning of the digestive system. This product is packaged in a gold resealable foil pouch; the product does not have the unit size labeled. Both products were distributed Nationwide to retail customers and via the internet.
RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Herbal Give Care LLC by calling to (972)602-6850 or email to firstname.lastname@example.org Monday- Friday from 9:00 am to 6:00 pm Central Standard Time.
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.htm
- 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
[07/23/2013 - Press Release - Herbal Give Care LLC]