Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack recalled over undeclared tadalafil

Recall date

April 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AMA Wholesale recalls Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709…

Recall number

D-0821-2018

FDA classification

Class I

Brand / firm

AMA Wholesale

Sold / distributed

Nationwide within the US

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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