Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients

[Posted 08/20/2013]

AUDIENCE: Consumer, Health Professional

ISSUE: Herbal Give Care LLC is voluntarily recalling all lots of Esbelder man (30 capsules), Esbelder fem (30 capsules) and Esbelder siloutte (30 capsules) to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. The presence of these undeclared ingredients makes these products unapproved drugs. 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 Esbelder fem (30 capsules) is packaged in a white plastic bottle with a screw cap containing 30 capsules per bottle. All lots of this product are being recalled. The product was distributed Nationwide to retail customers and via the internet and UPC code for this product is 7502011000251.

The Esbelder man (30 capsules) is packaged in a white plastic bottle with a screw cap containing 30 capsules per bottle. The product was distributed Nationwide to retail customers and via the internet and UPC code for this product is 7502011000275.

The Esbelder Siloutte (30 capsules) is packaged in a white plastic bottle with a screw cap containing 30 capsules per bottle. The product was distributed Nationwide to retail customers and via internet and UPC code for this product is 7502011000268.

RECOMMENDATION: Consumers with questions regarding this recall can contact Herbal Give Care LLC by calling to (972)602-6850 or email to hgc-usa@hotmail.com Monday- Friday from 9:00 am to 6:00 pm Central Daylight Time. 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.

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

[08/16/2013 - Press Release - Herbal Give Care LLC]