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Recall Observatory FDA recall evidence

Drug product

KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC

D-0297-2016

August 06, 2015

Class I

Product summary

Firm
Blue Square Market, Inc.
Event
Event 71912
Status
Terminated
Classification
Class I
Quantity
132 boxes
Official record key
drug-enforcement:D-0297-2016

Official wording

Reason: Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.

Code information: all lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.