WASHINGTON, D.C. — The U.S. Food and Drug Administration, FDA, declared a recall on all lots of “Active Male” in 500 mg capsules to the consumer level. The FDA announced that the “Active Male” natural supplement contains undeclared amounts of Tadalafil. Tadalafil is the active ingredient in erectile dysfunction medication. Consequently, the FDA declared a recall because the Natural Remedy Store, which sells “Active Male,” did not disclose the presence of Tadalafil in its product. The FDA did not approve “Active Male” for use with Tadalafil. As a result, the FDA has not studied the efficacy and safety of “Active Male” with Tadalafil added. The Natural Remedy Store said it had not received any complaints of adverse effects from men who used “Active Male.”
Tadalafil counteracts with medications containing nitrates. Nitroglycerin is an example of a drug containing nitrates. Therefore, a person who takes Tadalafil unexpectedly could experience a sudden and precipitous drop in blood pressure to life-threatening lows. Patients who take medication to combat high blood pressure, diabetes, high cholesterol, and heart disease are those who could experience a significant blood pressure drop.
The Natural Remedy Store sells “Active Male” as a supplement for boost sexual performance and enjoyment. The Natural Remedy Store packages “Active Male” in a cardboard package bearing a Trojan helmet with the designation B.N.: Nd6332. The store sells the product in its brick-and-mortar location in San Antonio, Texas, as well as through its online portal.
The Natural Remedy Store will notify its customers by press release. All consumers are advised to stop using the product at once. The store will arrange a return and refund of any samples remaining. Consumers can bring the purchase back to the store in San Antonio as well.
The FDA urges people to report adverse outcomes to its MedWatch Adverse Event reporting system via their website, mail, or fax.
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