FDA Recall D-0771-2016
Tf Supplements · Houston, TX
Class I — life-threatening Terminated 2428 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Reason for recall
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Recall record
- Recall number
D-0771-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2015-09-25
- Classified by FDA Center
- 2016-03-09
- FDA published
- 2016-03-16
- Terminated
- 2022-05-19
- Recalling firm
- Tf Supplements
- Firm location
- Houston, TX