Drug product
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.
D-0388-2021
Product summary
- Firm
- Bit & Bet LLC
- Event
- Event 87630
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3894 ten-count boxes (38,940 capsules)
- Official record key
drug-enforcement:D-0388-2021
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.