The FDA reported Friday that Herbal Give Care, LLC has issued a voluntary recall of three of its products: Esbelder Man, Esbelder Fem, and Esbelder Silhouette capsules, because they contained undisclosed dangerous ingredients. The FDA said in its press release:
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. To date, Herbal Give Care LLC has not received any reports of adverse events related to this recall.
Sibutramine has been voluntarily withdrawn from the market by its manufacturer Abbott Laboratories in many countries, including: Australia, Canada, China, the European Union (EU), Hong Kong, India, Mexico, New Zealand, Thailand, the United Kingdom, and the United States. It has been withdrawn from the US market since 2010. According to FDA officer Dr. John Jenkins, the “very modest weight loss” users achieve is not justified in light of their elevated “risk of heart attack or stroke.”
Since 2008, the FDA has issued repeated warnings about drugs containing undisclosed amounts of sibutramine.
If you are taking Esbelder Man, Esbelder Fem, or Esbelder Silhouette, the FDA advises that you discontinue immediately. Consumers are also encouraged to contact Herbal Give Care LLC, and to contact the FDA MedWatch Adverse Event Reporting program.
If you or a loved one has been affected by a product containing sibutramine, contact us at www.andrewsthornton.com or toll free at 1-800-644-1734.