Products found to contain undeclared medicines
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| The United States: Super Herbs issues voluntary nationwide recall of SUPER HERBS due to presence of undeclared sibutramine, desmethylsibutramine and/or phenolphthalein |
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Super Herbs is voluntarily recalling all bottles of SUPER HERBS, light green and dark green capsules to the consumer level after FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites 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. Phenolphthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established. Super Herbs has not received any reports of adverse events related to this recall.
The product is used as a weight loss dietary supplement and is packaged in clear bottle with light green and dark green capsules. The affected Super Herbs product includes all bottles which have been distributed nationwide to consumers via internet www.mysuperherbs.com. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm495546.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Wednesday, April 13, 2016
Issued at HKT 14:00 |
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