Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Product description
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
TX
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-0655-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 17, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 7 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Motto International Corp
Original FDA data
Every field from FDA enforcement report D-0655-2020, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84526
- Address
- 1908 Royal Ln Ste 700
- Code information
- All lots remaining within expiry.
- Postal code
- 75229-0269
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0655-2020
- Classification
- Class I
- Recalling firm
- Motto International Corp
- Product quantity
- 7 boxes
- Termination date
- Oct 29, 2021
- Reason for recall
- Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
- Distribution pattern
- TX
- Recall initiation date
- Dec 17, 2019
- Initial firm notification
- Press Release
- Center classification date
- Jan 10, 2020