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