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Recall Observatory FDA recall evidence

Drug product

Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.

D-0664-2021

March 30, 2021

Class I

Product summary

Firm
Ummzy, LLC
Event
Event 87624
Status
Terminated
Classification
Class I
Quantity
163 boxes/10 capsules per box
Official record key
drug-enforcement:D-0664-2021

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.