The U.S. Food and Drug Administration (FDA) announced that Herbal Give Care LLC is recalling all lots of three of its Esbelder products.
These products include Esbelder man (30 capsules), Esbelder fem (30 capsules), and Esbelder siloutte (30 capsules). The recall is taking place after the products were found to contain the hidden ingredients sibutramine, N-desmethylsibutramine, and N-di-Desmethylsibutramine. The presence of these undeclared components makes these products unapproved drugs.
Sibutramine is known to significantly increase blood pressure and/or pulse rate in some people. This ingredient may pose a health risk to those with a history of coronary artery disease, congestive heart failure, abnormal heart rhythms, or stroke. Herbal Give Care LLC has not received any reports of side effects related to the recall of these products.
All three products are packaged in a white plastic bottle with a screw cap, each containing 30 capsules. They were distributed nationwide to retail customers and were also sold on the internet. The Esbelder man bottles have the UPC code 7502011000275, the Esbelder fem bottles have the UPC code 7502011000251, and the Esbelder Siloutte have the UPC code 7502011000268.
Herbal Give Care LLC is notifying both consumers and distributors through phone calls and letters. The manufacturer is making arrangements for the return of all products that have been recalled. People who have these products should stop using them and immediately return them to the place where they were purchased.
Questions may be directed to Herbal Give Care LLC at 972.602.6850, Monday-Friday from 9:00 am to 6:00 pm Central Daylight Time. Anyone who has experienced problems or side effects that may be related to using these products should contact their doctor or healthcare provider.
The FDA advises consumers to also report any side effects to the FDA's MedWatch Adverse Event Reporting program either online, by mail, or by fax.
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