Products found to contain undeclared medicines
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| The United States: Lightning Rod Capsules: Recall - Undeclared Drug Ingredient Analogue of Sildenafil |
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The Food and Drug Administration (FDA) announced that Chang Kwung is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand name Lightning Rod (500 mg per capsule packaged in 3-count and 12-count bottles), because FDA testing found the Lightning Rod Capsules to contain an analogue of Sildenafil. Sildenafil is the active ingredient in an FDA-approved drug used for the treatment of male Erectile Dysfunction (ED), making Lightning Rod Capsules an unapproved new drug. The active drug ingredient is not listed on the label for 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. Customers in possession of Lightning Rod Capsules matching the description above are advised to return any unused product 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/MedWatch/../ucm351156.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been released by Health Canada and was posted on the website of Drug Office on 7 July 2012.
Ends/ Wednesday, May 08, 2013
Issued at HKT 12:00
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