Products found to contain undeclared medicines
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| The United States: Affirm XL, Inc Issues a Voluntary Nationwide Recall of Affirm XL Dietary Supplement Tablet (Lot 1190001) Due to Potential Health Risk |
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The Food and Drug Administration (FDA) announced that Affirm XL, Inc is conducting a voluntary nationwide recall to the consumer level of Affirm XL dietary supplement tablet specific to lot number 1190001, after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for this product. Affirm XL Tablet is marketed as a dietary supplement for sexual enhancement. It is sold nationwide in 10 count blister packs and single pill packs. There are no illnesses associated with this product. Use of this product may pose a threat to consumers because the analogue 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm347558.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been released by FDA and was posted on the website of Drug Office on 5 April 2013.
Ends/ Thursday, April 11, 2013
Issued at HKT 12:00
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