Drug product
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
D-0664-2021
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
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.