D-0673-2016 Class I Terminated
FDA drug recall D-0673-2016 was initiated by Premiere Sales Group on September 30, 2015 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. The recall status is terminated (terminated June 1, 2017).
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2016
- Initiation Date
- September 30, 2015
- Termination Date
- June 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Distribution Pattern
Nationwide
Code Information
All lots