Lightning Rod Capsules: Recall - Undeclared Drug Ingredient

[Posted 05/07/2013]

AUDIENCE: Consumer

ISSUE: Chang Kwung announced today that it 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, UPC 6 89076 20257 2 and 12-count bottles, UPC 6 89076 20297 8), 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.

BACKGROUND: Lightning Rod capsules are sold over the counter as a dietary supplement marketed for male sexual enhancement. It is sold nationwide via internet in 3 capsule count and 12 capsule count bottles between August 2012 and May 3, 2013.

RECOMMENDATION:  Customers in possession of Lightning Rod Capsules matching the description above are to return any unused product, for a full refund, to the company directly. Consumers with questions regarding this recall can call 747-444-1843, Monday through Friday 9:00 AM to 5:00 PM PST, for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/07/2013 -Press Release - Chang Kwung]