Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Product description
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
Lot numbers, UPCs & expiration codes
all lots within expiry.
Where it was sold
TX
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-1117-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 25, 2017
- FDA report date
- Aug 30, 2017
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Brian P. Richardson
Original FDA data
Every field from FDA enforcement report D-1117-2017, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77375
- Address
- 3410 Delafield Ln
- Code information
- all lots within expiry.
- Postal code
- 75227-5313
- Report date
- Aug 30, 2017
- Product type
- Drugs
- Recall number
- D-1117-2017
- Classification
- Class I
- Recalling firm
- Brian P. Richardson
- Product quantity
- Unknown
- Termination date
- Feb 10, 2021
- Reason for recall
- Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
- Distribution pattern
- TX
- Recall initiation date
- May 25, 2017
- Initial firm notification
- Press Release
- Center classification date
- Aug 22, 2017