Products found to contain undeclared medicines
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| The United States: Shoreside Enterprises issues voluntary nationwide recall of 7K and Poseidon 4500 (Extreme 1000 mg) due to presence of undeclared sildenafil and tadalafil |
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The US Food and Drug Adminstration (FDA) announces that Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). The presence of sildenafil and tadalafil renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered tainted. To date, Shoreside Enterprises, Inc. has not received any reports of adverse events related to this recall.
The products are marketed as dietary supplements for male sexual enhancement. The products can also be identified by their blue color, and lot numbers located on their individual packaging. These products are packaged in 1 capsule blister packs. These products were distributed from 2 Feb 2017 to 19 Dec 2017, to retail locations in Illinois, Ohio, North Carolina, Massachusetts, and Florida by Shoreside Enterprises.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm608074.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, May 18, 2018
Issued at HKT 16:00
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