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Recall Observatory FDA recall evidence

Drug product

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

D-0126-2018

August 01, 2017

Class I

Product summary

Firm
The Ampt Life, LLC
Event
Event 77859
Status
Terminated
Classification
Class I
Quantity
1380 packets
Official record key
drug-enforcement:D-0126-2018

Official wording

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.

Code information: All lots

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Undeclared allergen

    reason.undeclared_allergen · v1.0.0

    undeclared sildenafil and tadalafil and undeclared milk