Why it was recalled
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Product description
Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Lot numbers, UPCs & expiration codes
All lots
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-0672-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 30, 2015
- FDA report date
- Feb 24, 2016
- Quantity
- 337 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Premiere Sales Group
Original FDA data
Every field from FDA enforcement report D-0672-2016, exactly as published.
Show all FDA fields
- City
- Santa Clarita
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 72522
- Address
- 21446 Golden Triangle Rd
- Code information
- All lots
- Postal code
- 91350-2911
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0672-2016
- Classification
- Class I
- Recalling firm
- Premiere Sales Group
- Product quantity
- 337 bottles
- Termination date
- Jun 1, 2017
- Reason for recall
- Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 30, 2015
- Initial firm notification
- Center classification date
- Feb 16, 2016