Miami Company Recalls Erectile Dysfunction Capsules: Might Work, Might Not

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A Miami Gardens company has recalled a libido enhancer that was deemed an “unapproved drug” by the FDA.

The FDA did not say that Noah Wholesale’s “The Rock” does not work, and according to Noah’s recall notice, “The Rock” contains sildenafil, the active ingredient that makes Viagra work.

That is the problem.

The recall notice states, “Because this product contains sildenafil, The Rock is an unapproved drug whose safety and effectiveness have not been established and is subject to recall.”

Sildenafil, which is undeclared on the package insert, is not necessarily compatible with nitrates, which may be found in other prescription drugs that people take. This can result in a drop in blood pressure and death.

People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.” Among adult men most likely to use this product, adult men using nitrates for heart disease are most at risk.”

Each red 1200 mg capsule was sold alone in blister packs with red and black writing on white cardboard. The recalled lot is No. 03032021 with an expiration date of December 2007 and UPC No. 6 61799 95052 7. Steele Products of Hallandale Beach sold the capsules through local convenience stores, gas stations, and small wholesalers.

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