Drug product
Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
D-0366-2021
Product summary
- Firm
- Antoto-K
- Event
- Event 87627
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 cartons
- Official record key
drug-enforcement:D-0366-2021
Official wording
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Code information: All lots within expiry.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.