Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0126-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 1, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 1380 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Ampt Life, LLC
Original FDA data
Every field from FDA enforcement report D-0126-2018, exactly as published.
Show all FDA fields
- City
- Frisco
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77859
- Address
- 5134 Navajo Dr
- Code information
- All lots
- Postal code
- 75034-1275
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0126-2018
- Classification
- Class I
- Recalling firm
- The Ampt Life, LLC
- Product quantity
- 1380 packets
- Termination date
- Sep 6, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 1, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 21, 2017