D-0126-2018 Class I Terminated
FDA drug recall D-0126-2018 was initiated by The Ampt Life, LLC on August 1, 2017 and is designated Class I. 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 He… The recall status is terminated (terminated September 6, 2018). Affected quantity: 1380 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- December 27, 2017
- Initiation Date
- August 1, 2017
- Termination Date
- September 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1380 packets
Product Description
NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
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.
Distribution Pattern
Nationwide in the USA
Code Information
All lots