Bit & Bet LLC: Drug Recall
Recall #D-0388-2021 · 03/24/2021
Class II: Risk
Recall Details
- Recall Number
- D-0388-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Bit & Bet LLC
- Status
- Terminated
- Date Initiated
- 03/24/2021
- Location
- Cliffside Park, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3894 ten-count boxes (38,940 capsules)
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Product Description
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.
Distribution Pattern
Nationwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.