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U.S. Department of Health and Human Services

Safety

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X-ROCK 3 Day Pill For Men and Z-ROCK: Recall – Undeclared Drug Ingredient

 
[Posted 07/24/2012]
 
AUDIENCE: Consumer
 

ISSUE: CRM Laboratories is conducting a consumer/user level recall of all X-ROCK 3 Day Pill For Men and Z-ROCK products sold between October, 2011 and April, 2012. Finished product of X-ROCK 3 Day Pill for Men and Z-ROCK was tested and found to contain an analogue of an ingredient in an FDA-approved drug. Analytical tests conducted by the FDA concluded that the products contained sildenafil and hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil and is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in a FDA approved drug that is used to treat erectile dysfunction (ED) making these products unapproved new drugs.

These undeclared active ingredients pose a threat to consumers because sildenafil and hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
  
BACKGROUND: The products were sold as wholesale in the US to distributors who further distributed it nationwide through internet sales and at retail.
  
RECOMMENDATION: Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking this product.
 
The Company is advising consumers to return any unused products, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly. 
  
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
 
[07/24/2012 - Press Release – CRM Laboratories]