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The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from US FDA on the recall of all lots of Max health Hydro Pineapple Burn manufactured by Jongu 4308 because FDA analysis has found the product to contain undeclared sibutramine.
The presence of sibutramine in Max health Hydro Pineapple Burn renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to recall. This tainted product is marketed as a dietary supplement for weight loss and is packaged in a box containing ten 20g sachets. Hydro Pineapple Burn was distributed by eBay via internet at www.ebay.comExternal Link Disclaimer nationwide in the USA. To date, Jongu 4308 has not received any report of adverse events related to this recall.
BACKGROUND: Max Health Hydro Pineapple Burn is marketed as a dietary supplement for weight 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 Sibutramine was an FDA approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues.
RISK STATEMENT: 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.
Below is an image of the recalled product;
RECOMMENDATION:
NAFDAC implores importers, distributors, retailers and consumers who have Hydro Pineapple Burn in their possession or storage to stop distribution, sale and use and submit to the nearest NAFDAC office.
Consumers are advised to avoid certain regulated products found on eBay, Amazon and other on-line retailers due to hidden and potentially dangerous drug ingredients
NAFDAC encourages consumers and health care professionals to report adverse events related to the use of these recalled product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or NAFDAC Med Safety Mobile App.
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
