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. (more…)