How FDA drug recalls work
The makers of two kinds of erectile dysfunction drugs yanked them from circulation this week after the FDA declared them “unapproved drugs” whose safety and effectiveness haven’t been proven.
The FDA says what caused this declaration about Stiff Boy’s The Beast and DBP Distribution’s Titanium 4000 is the unstated presence of phosphodiesterase (PDE-5) inhibitors, sildenafil (both) and tadalafil (Titanium 4000), both FDA-approved active ingredients for dealing with erectile dysfunction. Sildenafil is the active ingredient in Viagra and tadalafil is what puts the go in Cialis.
“Consumption of a product with undeclared PDE-5 inhibitors may pose a threat to consumers because the active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels which can be life threatening,” The Beast’s recall notice says. “Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected.”
The Beast was sold online in blue wrapping, in a blue box, four capsules per package with no UPC bar code. Anyone with questions can contact the company at 914-281-4059, Monday through Friday, 9 a.m. to 5 p.m., Eastern time, or by email at email@example.com.
Titanium 4000’s recall notice says, it “was distributed nationwide to users via the internet. And from discountbonerpills.com.”
Anyone with questions can contact DBP at 818-262-9951, Monday thru Friday, noon to 8 p.m., Eastern time, email orders@firstname.lastname@example.org.