Products found to contain undeclared medicines
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| The United States: Nutra Labs Inc. issues voluntary nationwide recall of dietary supplements Bull and Chao Jimengnan tablets due to undeclared active pharmaceutical ingredients sildenafil |
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The Unitd States (US) Food and Drug Administration (FDA) announces that Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs.
Use of products with undeclared sildenafil 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 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. As on 30 November 2017, Nutra Labs Inc. has not received any reports of adverse events related to this recall.
The products are marketed as dietary supplements for male sexual enhancement and are packaged as follows: Bull – 30 pills per tin, Chao Jimengnan – 4 pills per box.
The affected lots include the following expiration dates: Bull – 05-07-2019, Chao Jimengnan – 10/2017. The products can be identified by the word ‘Bull’ with an image of a Bull on a black tin in the case of ‘Bull’, and a square red box with ‘Chao Jimengnan Super Powerful Man Tablets’ printed on the front. Bull and Chao Jimengnan were distributed Nationwide via internet.
Nutra Labs Inc. is notifying its customers by e-mail and is arranging for return of all recalled products.
Please refer to the following website in FDA for details:http://www.fda.gov/Safety/Recalls/ucm587141.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, December 1, 2017
Issued at HKT 15:00
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