Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Product description
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide within the US
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-0821-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 12, 2018
- FDA report date
- May 30, 2018
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMA Wholesale
Original FDA data
Every field from FDA enforcement report D-0821-2018, exactly as published.
Show all FDA fields
- City
- Chino Hills
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79852
- Address
- 4195 Chino Hills Pkwy
- Address (line 2)
- #609
- Code information
- All Lots
- Postal code
- 91709-2618
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0821-2018
- Classification
- Class I
- Recalling firm
- AMA Wholesale
- Product quantity
- unknown
- Termination date
- Apr 7, 2021
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Apr 12, 2018
- Initial firm notification
- Press Release
- Center classification date
- May 18, 2018