D-0821-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- April 12, 2018
- Termination Date
- April 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
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
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.
Distribution Pattern
Nationwide within the US
Code Information
All Lots