FDA MedWatch - Hydro Pineapple Burn by Jongu 4308:

Recall - Due to the Presence of Undeclared Sibutramine

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Hydro Pineapple Burn by Jongu 4308: Recall - Due to the Presence of Undeclared Sibutramine AUDIENCE: Consumer, Health Professional, Pharmacy ISSUE: eBay Seller: Jongu 4308 is recalling all lots of Hydro Pineapple Burn because FDA analysis has found the product to contain undeclared sibutramine. The presence of sibutramine in Hydro Pineapple Burn renders it as an unapproved drug for which safety and efficacy has not been established and therefore subject to recall. Products containing sibutramine pose a health risk 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 history of coronary artery disease, congestive heart failure, arrhythmias or stroke. To date, Jongu 4308 has not receive any report of adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Hydro Pineapple Burn is marketed as a dietary supplement for weigh loss.  Sibutramine was an FDA approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues.  RECOMMENDATIONS: FDA issued a press release that warned consumers to avoid certain products found on eBay, Amazon, and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Consumers that have Hydro Pineapple Burn, which is being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact eBay Seller ID: Jongu 4308. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and consumers 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. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA