Natural Herbal Coffee Ampt…

Date

Dec. 27, 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

The Ampt Life, LLC

Product

NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.

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.

Distribution pattern

Nationwide in the USA

Quantity

1380 packets

Codes and lots

All lots

Recall started

Aug. 1, 2017

Recall number

D-0126-2018

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0126-2018. The agency record governs; check it and the company before acting.