FDA recall D-0821-2018

Product

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

Nationwide within the US

Key facts

Status

Terminated

Initiation date

2018-04-12

Report date

2018-05-30

Termination date

2021-04-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chino Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0821-2018