Why it was recalled
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.
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0388-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 24, 2021
- FDA report date
- May 26, 2021
- Quantity
- 3894 ten-count boxes (38,940 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bit & Bet LLC
Original FDA data
Every field from FDA enforcement report D-0388-2021, exactly as published.
Show all FDA fields
- City
- Cliffside Park
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87630
- Address
- 25 Oakdene Ave
- Code information
- All lots within expiry.
- Postal code
- 07010-3009
- Report date
- May 26, 2021
- Product type
- Drugs
- Recall number
- D-0388-2021
- Classification
- Class II
- Recalling firm
- Bit & Bet LLC
- Product quantity
- 3894 ten-count boxes (38,940 capsules)
- Termination date
- Jul 16, 2021
- Reason for recall
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Mar 24, 2021
- Initial firm notification
- Press Release
- Center classification date
- May 18, 2021