Products found to contain undeclared medicines
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| The United States: Regeneca, Inc. issues a voluntary nationwide recall of all lots of single capsule RegenErect due to the presence of undeclared Tadalafil |
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Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement. The company, through independent lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products. Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm293376.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Saturday, February 25, 2012
Issued at HKT 12:00 |
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