Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Product description
Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 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-0656-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 17, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 5 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Motto International Corp
Original FDA data
Every field from FDA enforcement report D-0656-2020, 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-0656-2020
- Classification
- Class I
- Recalling firm
- Motto International Corp
- Product quantity
- 5 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
- Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 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