PlainRecalls
FDA Drug Critical Class I Terminated

Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128

Reported: May 30, 2018 Initiated: April 12, 2018 #D-0821-2018

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.

Details

Recalling Firm
AMA Wholesale
Units Affected
unknown
Distribution
Nationwide within the US
Location
Chino Hills, CA

Frequently Asked Questions

What product was recalled?
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128. Recalled by AMA Wholesale. Units affected: unknown.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 30, 2018. Severity: Critical. Recall number: D-0821-2018.