US/Silver Spring: Chang Kwung recalls some Lightning Rod Dietary Supplements due to undeclared drug hazard. FDA: http://ht.ly/kNOEa
Direct link: http://www.fda.gov/Safety/Recalls/ucm351058.htm
The US Food and Drug Administration (“FDA”) reports that analytical testing by the US FDA found Chang Kwung’s Lightning Rod Dietary Supplement Capsules contain an analogue of Sildenafil, a controlled drug. 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.
According to the FDA, 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 substance may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with Diabetes, Hypertension (high blood pressure), high cholesterol and/or heart disease often take nitrates for symptom control. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of Supplements to enhance sexual performance.
The FDA says the Lightning Rod capsules were sold over the counter as a dietary supplement marketed for male sexual enhancement. They were sold nationwide in the US over the Web in 3-capsule count and 12-capsule count bottles between August 2012 and May 3, 2013.