FDA Recall D-0126-2018

The Ampt Life, LLC · Frisco, TX

Class I — life-threatening Terminated 401 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: All lots

Quantity: 1380 packets

Reason for recall

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.

Recall record

Recall number: D-0126-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide in the USA
Recall initiated: 2017-08-01
Classified by FDA Center: 2017-12-21
FDA published: 2017-12-27
Terminated: 2018-09-06
Recalling firm: The Ampt Life, LLC
Firm location: Frisco, TX

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