Products found to contain undeclared medicines
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| The United States: Beamonstar Products issues Voluntary Nationwide Recall of SexVoltz, Velextra, & Amerect Marketed as a Dietary Supplement, due to Undeclared Active Ingredients Tadalafil - Expanded to include SexVoltz 12 Capsules Bottle |
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The Food and Drug Administration (FDA) announced that Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand, Velextra brand and Amerect capsules to the consumer level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs. These undeclared active ingredients poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
BeaMonstar Products has not received any reports of adverse events to date related to this recall. The product is used as a sexual enhancement product and all 3 products are packaged in blister type packaging in 1 & 2 caps blister, and in 4, 10 & 12 capsule bottles. The affected ‘Maximum Strength’ SexVoltz, Velextra, and Amerect are all lots distributed and sold from January of 2012 to May 7, 2013 and contain various expiration dates. SexVoltz, Velextra, and Amerect was distributed Nationwide to wholesalers, retail, and via internet. 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/ucm351847.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news has been released by FDA and was posted on the website of Drug Office on 9 May 2013.
Ends/ Saturday, May 11, 2013
Issued at HKT 12:00
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