Recall Record

Chino Hills, CA, United States

AMA Wholesale recalls

1 recall recorded since 2018, most recently on 12 April 2018. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1

Terminated Class I Drugs

Recall started
12 April 2018
Terminated
7 April 2021
Reason
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
Initiated
Voluntary: Firm initiated
Recall number
D-0821-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.