Drug product
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
D-1117-2017
Product summary
- Event
- Event 77375
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1117-2017
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Code information: all lots within expiry.
Distribution pattern: TX
Derived failure modes
-
Undeclared allergen
undeclared milk