US Drug Recall Register
Class I · High risk Terminated Initiated May 25, 2017 (9 years ago)

CaverFlo Natural Herbal Coffee

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk

What was recalled

CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987

Recalling firm
Brian P. Richardson
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1117-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

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Class I · High risk Terminated

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Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.

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Class I · High risk Terminated

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Reason Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.

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