FDA Recall D-1117-2017
Brian P. Richardson · Dallas, TX
Class I — life-threatening Terminated 1357 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Recall record
- Recall number
D-1117-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- TX
- Recall initiated
- 2017-05-25
- Classified by FDA Center
- 2017-08-22
- FDA published
- 2017-08-30
- Terminated
- 2021-02-10
- Recalling firm
- Brian P. Richardson
- Firm location
- Dallas, TX