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Recall Observatory FDA recall evidence

Drug 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

D-0821-2018

April 12, 2018

Class I

Product summary

Firm
AMA Wholesale
Event
Event 79852
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-0821-2018

Official wording

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.

Code information: All Lots

Distribution pattern: Nationwide within the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.