FDA Recall D-0673-2016
Premiere Sales Group · Santa Clarita, CA
Class I — life-threatening Terminated 610 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
Reason for recall
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Recall record
- Recall number
D-0673-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2015-09-30
- Classified by FDA Center
- 2016-02-16
- FDA published
- 2016-02-24
- Terminated
- 2017-06-01
- Recalling firm
- Premiere Sales Group
- Firm location
- Santa Clarita, CA