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Recall Observatory FDA recall evidence

Drug product

Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

D-0656-2020

December 17, 2019

Class I

Product summary

Firm
Motto International Corp
Event
Event 84526
Status
Terminated
Classification
Class I
Quantity
5 boxes
Official record key
drug-enforcement:D-0656-2020

Official wording

Reason: Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Code information: All lots remaining within expiry.

Distribution pattern: TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil