Jack Distribution Recalls Sex Supplements

POMPANO BEACH, Fla.—Jack Distribution LLC started a nationwide recall on July 1 for certain lots of its Rize 2 The Occasion and Rose 4 Her dietary supplements, after the company was informed by FDA that product testing found undeclared, potentially harmful ingredients. The affected products contained thiomethisosildenafil, an analog of sildenafil, an active pharmaceutical ingredient for erectile dysfunction (ED).

The company noted unused portions from these lot numbers could be returned to place of purchase for a full refund, and that its wholesale distributors, G & N Words Inc. and Devine Distribution Inc., have suspended shipping on all lots of the products pending additional product testing.

In a statement posted on the FDA Web site, Jack Distribution noted it initiated the voluntary recall to protect consumers’ health and is reviewing its production procedures, as well as those of all firms involved with manufacturing the products, to ensure future compliance with federal regulations.

The affected lots were Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10; and Rose 4 Her lot number CG-78 expires 11/10. Any adverse events that may be related to the use of these products should be reported to FDA’s MedWatch Program.