According to the FDA, AMA Wholesale Inc. is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. Analysis by the FDA found that the product is tainted with tadalafil, which was not declared on the ingredient label. Tadalafil is an active ingredient in an FDA-approved prescription drug used for erectile dysfunction.
Customers who are not aware of the addition of tadalafil to this supplement could suffer serious cardiovascular collapse if they have underlying health issues. These health issues include cardiovascular disease (from diabetes, hypertension, etc.). This is due to the chance of individuals with diabetes, hypertension, high cholesterol, or heart disease taking nitrates; concomitant use of nitrates and PDE5 inhibitors (like tadalafil) can lead to fatal cardiovascular collapse.
According to D. Miller Law, a defective drug lawyer, the FDA has recently opened its extensive database of adverse reports to the public. It is now possible for consumers to search through millions of reports of side effects caused by prescription drug use with the new initiative, called Open FDA. According to their website, “OpenFDA is specifically designed to make it easier for developers, researchers, and the public to access and use the many large, important, health data sets collected by the agency.”
Patients and doctors depend on the information provided by drug manufacturers, including supplements. Incorrect labeling can cause serious side effects or interactions when these products are incorrectly or intentionally mislabeled.
Newsday reports that 70% of the nation’s supplement companies have gone against the FDA’s manufacturing regulations. In addition to mislabeled or omitted ingredients on the label, other factors include poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, and even bacteria in pediatric vitamins.
With a reported 150 million people in the United States- roughly half of the total population- consuming vitamins, mineral tablets, weight-loss aids, herbal remedies, protein powders and an increasing amount of other products that fall under the title of dietary supplements, there is no sure way for consumers to know what they are actually putting into their bodies.
Rhino 69 Extreme 50000 is used as a sexual enhancer and was distributed nationwide via internet sales. It is packaged in a single capsule, blister pack with an expiration date of 12/2022 and UPC Code 718122071128. AMA Wholesale Inc. is notifying customers via email of the recall. It appears the recalled product has been replaced, as there are several sources currently offering the product for sale online.
As of April 12, 2018, no reports of adverse events have been reported related to the recall. Consumers who have experienced any problems that may be related to taking or using the product should contact their physician or healthcare provider.
Customers who have purchased this product should immediately stop using it and return it to the place of purchase for a refund. Questions can be directed to AMA Wholesale Inc. via phone at 1 (800) 689-6532.