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A Miami Gardens company has recalled its sexual enhancement pill after the FDA declared it an “unapproved drug.”

The agency didn’t say Noah Wholesale’s The Rock didn’t work, and Noah’s recall notice says The Rock has sildenafil, the active ingredient that makes Viagra work.

That’s the problem.

“The presence of sildenafil in this product renders the rock an unapproved drug for which the safety and efficacy has not been established and, therefore, can hydrocodone cause gastritis subject to recall,” the recall notice states.

Sildenafil, which was undeclared on the packaging, doesn’t always mix well with nitrates, which might be in other prescription drugs a person is taking. The resulting drop in blood pressure can be deadly.

“People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates,” the recall notice’s risk statement says. “Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.”

Each red 1200 mg capsule was sold solo in a blister pack with red and black lettering on a white piece of cardboard. The recalled lot is No. 03032021, expiration 12/2007 with UPC No. 6 61799 95052 7. Hallandale Beach’s Steele Products distributed the capsules through local convenience stores, gas stations and small wholesalers.

2023 Miami Herald. Distributed by Tribune Content Agency, LLC.

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