X-ROCK 3 Day Pill for Men and Z-ROCK Recalled due to Undeclared Drug Ingredient that Pose a Threat to Consumers

A consumer/user level recall of all X-ROCK 3 Day Pill for Men and Z-ROCK products is conducted as they contain undeclared active ingredients that pose a threat to consumers by lowering blood pressure to dangerous levels.

Background of X-ROCK 3 Day Pill for Men and Z-ROCK

X-ROCK 3 Day Pill for Men and Z-ROCK, by CRM Laboratories, were sold to distributors in the US who sold it via internet and retail nationwide.

FDA Alert on X-ROCK 3 Day Pill for Men and Z-ROCK

After analytical tests of X-ROCK 3 Day Pill for Men and Z-ROCK finished product were conducted by the FDA, it was found to contain undeclared ingredient sildenafil and hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil and active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED). This makes the above products unapproved drugs.

Furthermore, it poses a threat to consumers as these ingredients may interact with nitrates in some prescription drugs (like nitroglycerin) and lower blood pressure to levels that are dangerous.

Recommendation on X-ROCK 3 Day Pill for Men and Z-ROCK

“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.”

Contacting the FDA to report cases with X-ROCK 3 Day Pill for Men and Z-ROCK

In case of detection of adverse events or side effects related to the use of X-ROCK 3 Day Pill for Men and Z-ROCK, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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