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Recall Observatory FDA recall evidence

Drug product

Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA

D-0672-2016

September 30, 2015

Class I

Product summary

Firm
Premiere Sales Group
Event
Event 72522
Status
Terminated
Classification
Class I
Quantity
337 bottles
Official record key
drug-enforcement:D-0672-2016

Official wording

Reason: Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.