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Recall Observatory FDA recall evidence

Drug product

Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860

D-0662-2021

March 30, 2021

Class I

Product summary

Firm
Ummzy, LLC
Event
Event 87624
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0662-2021

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Code information: All lots within expiry.

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.