One Third of FDA Approved Drugs Experience Some Kind of Recall

Synopsis

  • A recent FDA analysis has concluded that the sexual enhancer drug, Rhino
    69 Extreme 50000 is tainted with undeclared tadalafil. The analysis has
    caused the drug’s wholesaler to initiate a voluntary recall.
  • Tadalafil is an active ingredient in a FDA-approved prescription drug that
    is used for erectile dysfunction.
  • Some Rhino 69 consumers with underlying cardiovascular diabetes, hypertension,
    high cholesterol or heart disease, could face fatal consequences when
    mixing the enhancer with regular medicines like nitrates.
  • So far, there have not been any reports of adverse events related to this
    recall but in 2017, the American Medical Association released a report
    showing that many drugs the FDA approves are involved in some kind of
    recall or safety event after being released to consumers.

Sexual Enhancement Drug on FDA’s Recall Watchlist

On April 18, 2018, AMA Wholesale Inc.
voluntarily recalled Rhino 69 Extreme 50000 capsules at the consumer level after a U.S. Food & Drug Administration (FDA)
analysis found the product to be tainted with undeclared tadalafil. Tadalafil
is an active ingredient in a FDA-approved prescription drug that is used
for erectile dysfunction. As of April 24, 2018, the distributor had not
yet received any reports of adverse events related to this recall.

According to the FDA, “consumers who take supplements for erectile
dysfunction could have underlying cardiovascular disease (from diabetes,
hypertension, and others). Consumers with diabetes, hypertension, high
cholesterol or heart disease often take nitrates; concomitant use of nitrates
and PDE5 inhibitors can lead to fatal cardiovascular collapse.”

About the Rhino 69 Extreme 50000 Recall

Rhino 69 Extreme 50000 is used as a sexual enhancer and is packaged in
single capsule, blister packs with an expiration date of 12/2022 and UPC
Code: 718122071128. The product was distributed nationwide via internet
sales to the customers. AMA Wholesale Inc. (Distributor/Re-seller) is
notifying its customers by E-Mail and is arranging for return of the recalled product.

Consumers/distributors/retailers that have purchased ‘Rhino 69 Extreme
50000’ should immediately stop the consumption and the resale of
the product and return the product to the place of purchase for a refund.

1/3 of FDA Approved Drugs Recalled From 2001 and 2010

About a third of the drugs the FDA approved between 2001 and 2010 were
involved in some kind of safety event after reaching the market, according
to a 2017 study published in the Journal of the American Medical Association.
Additional conclusions to the study found that:

  • 222 novel therapeutics had been approved.
  • There were 123 post-market safety events involving 71 products that required
    FDA warning or recall action.
  • 3 were withdrawn while 61 received new boxed warnings and 59 required enhanced
    safety communications.

To get FDA approval, the majority of the drugs with safety events were
trialed in 1,000 or fewer patients.

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