[Posted 07/15/2013]

AUDIENCE: Consumer

ISSUE: Hardmenstore.com recalled 430 lots of Silver Sword and Clalis at the consumer level. Silver Sword and Clalis have been found to contain Sildenafil, which could cause adverse reactions and drug interactions normally associated with the active ingredient in Viagra. Use of these products can result in decreased blood pressure, light-headedness, and dizziness.

The affected Silver Sword and Clalis lots include those produced on or before April 2, 2013.

BACKGROUND: These products are intended to be used as a dietary supplement and sexual supplement. Silver Sword is packaged in a tin containing 8 doses, 2 pills per dose. Clalis is packaged in box containing a bottle of 6 pills. The production date is stamped on the back of the packaging.

RECOMMENDATION: Consumers and retailers that have the Silver Sword or Clalis supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt.

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

[07/05/2013 - Press Release - Hardmenstore.com] [07/15/2013 - Product Photos - FDA]

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