Why it was recalled
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Product description
Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
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-0366-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 26, 2021
- FDA report date
- May 12, 2021
- Quantity
- 200 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Antoto-K
Original FDA data
Every field from FDA enforcement report D-0366-2021, exactly as published.
Show all FDA fields
- City
- Manassas
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 87627
- Address
- 7686 Chadds Landing Way
- Code information
- All lots within expiry.
- Postal code
- 20111-1772
- Report date
- May 12, 2021
- Product type
- Drugs
- Recall number
- D-0366-2021
- Classification
- Class II
- Recalling firm
- Antoto-K
- Product quantity
- 200 cartons
- Termination date
- Apr 18, 2022
- 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 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 26, 2021
- Initial firm notification
- Press Release
- Center classification date
- May 4, 2021