Products found to contain undeclared medicines
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| The United States: Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and Tadalafil |
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The US Food and Drug Administration (FDA) analysis found samples of Super Panther 7K, distributed by SX Power Co., Brooklyn, NY, to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED). The presence of sildenafil and tadalafil in Super Panther 7K renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
Consumers who take this product for erectile dysfunction could have underlying cardiovascular disease. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse.
Super Panther 7K is marketed as a dietary supplement for sexual enhancement and packaged in Super Panther 7K capsules, 6-count bottles UPC 6 01577 51320 9, Exp 8/28/2020 lot RO246852 1-count blister cards UPC 6 015577 51324 7, and 30-count hanging card display UPC 015577 51324 7, and lot RO846356, Exp 08/28/2020. Super Panther 7K was sold to consumers nationwide in the USA via our retail website. Ultra Shop Supplements has discontinued sales of these products and has notified its customers of this voluntary recall via e-mail.
Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm568031.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 23 June 2017.
Ends/ Saturday July 22, 2017
Issued at HKT 12:00
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