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FDA · Drug recall

CaverFlo Natural Herbal Coffee…

Aug. 30, 2017 Class I

Date
Aug. 30, 2017
Risk class
Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status
Terminated
Filed by
Brian P. Richardson
Product
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
Reason
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Distribution pattern
TX
Quantity
Unknown
Codes and lots
all lots within expiry.
Recall started
May 25, 2017
Recall number
D-1117-2017

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1117-2017. The agency record governs; check it and the company before acting.

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