April 23, 2012

1 Min Read
XROCK Recalls Sexual Enhancement Product

FORT LAUDERDALE, Fla.XROCK INDUSTRIES issued a statement that it is conducting a voluntary recall of all codes of the X-ROCK for Men sexual enhancement products, after FDA informed the company that its testing found the products contained sildenafil and hydroxythiohomosildenafil, an analogue of sildenafil. The compounds are FDA-approved pharmaceuticals used to treat erectile dysfunction (ED).

The use of the adulterated products, which were sold in single blister cards, may pose a health concern to consumers, as the drug analogue can interact with nitrates found in other pharmaceuticals and lower blood pressure to dangerous levels. XROCK INDUSTRIES is advising consumers to stop using the product immediately and return any unused producteither to the retail location from which it was purchased or to the company directly if it was purchased onlinefor a refund of the full price. Consumers and health care providers can also report any adverse reactions to the products to FDAs MedWatch Adverse Event Reporting program online. The recall is being conducted with FDAs knowledge.

XROCK INDUSTRIES said it has not received any reports of adverse events related to this recall. It further stated it is reviewing the procedures of all companies involved with the manufacturing of its products, and is committed to the "quality and integrity" of its products; the firm also noted it regrets the "incomplete" X-ROCK labeling information.

INSIDER's Take: Any product labeled as a dietary supplement cannot contain pharmaceutical ingredients; it's not incomplete labeling information. That's adulteration, if you're not aware, or marketing an unapproved new drug if you are. Learn more about ensuring quality in your supply chain in the session Monitoring Supply and Detecting Contamination/Adulteration at SupplySide MarketPlace.

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