Jack Distribution, LLC, located at 1501 Green Road Unit C Pompano Beach, Florida 33064, and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company’s defective supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. We reported earlier this month that a voluntary, nationwide recall of selected lots of these products were recalled because because some lots contained thiomethisosildenafil, an undeclared ingredient similar in chemical structure to sildenafil, an FDA-approved erectile dysfunction (ED) medication.
Jack Distribution, LLC, is conducting this recall after being informed by the Food and Drug Administration (FDA) that lab analysis of Rize 2 and Rose 4 Her samples of random lots found the product contains potentially harmful, undeclared ingredients. FDA states that its chemical analysis found Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil and is expected to possess a similar pharmacological and adverse event profile, thus posing a potential threat to consumers because it may interact with nitrates found in some prescription drugs—such as nitroglycerin—and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and ED is a common problem in men with these conditions; therefore, consumers may take these products to enhance sexual performance.
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. Also, adverse events related to the use of these products should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Jack Distribution states that unused portions can be returned to the place of purchase for a full refund of the purchase price and that it will manufacture new lots of these products, which are not subject to the recall and whose lot numbers will begin with “BL” and will begin to be sold shortly.
Rize 2 and Rose 4 Her are sold in adult stores, vitamin and nutrition shops, convenience stores, and via the Internet nationwide. The Rize 2 product is sold as a single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.
Meanwhile, this is not the first such recall of this kind. In May, International Pharmaceuticals, Ltd. of Bradford, Massachusetts recalled lots of its supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs and SEI Pharmaceuticals of Miami, Florida recalled lots of Xiadafil VIP Tabs. Both recalls were implemented after samples were also found to contain a potentially harmful undeclared ingredient—an analog of sildenafil, an FDA-approved ED medication.
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April 29th, 2009 at 10:57 pm
The product was harmless. All that was needed was a warning not to take it if you are taking medications with nitrates. Brand name Viagra and Cialis are affordable over-the-counter products overseas and men eat them like candy. ‘Been there; done that. The FDA merely targeted Rise 2 in the U.S. because it was eating into the Phizer pharmaceutical monopoly. There is *NO* other logical reason, and there is no reason for Viagra and Cialis to be subscription and as expensive as they are in the states either. ‘More ways of owning you cradle to the grave.