Products found to contain undeclared medicines
|
| |
| The United States: SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient Tadalafil |
| |
FDA announced that BeaMonstar Products is recalling its SexVoltz, Velextra, and Amerect capsules to the retail 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 is an FDA-Approved drug used to treat male erectile dysfunction (ED), making the products unapproved new drugs. This undeclared active ingredient 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. 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. The product is used as a sexual enhancement product and all 3 products are packaged in blister type packaging in 1 & 2 caps, and in 4 capsule and 10 capsule bottles. SexVoltz, Velextra, and Amerect was distributed Nationwide to wholesalers, retail, and via the 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/MedWatch/../ucm351181.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Thursday, May 09, 2013
Issued at HKT 13:00
|
| |
|
