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Recall Observatory FDA recall evidence

Drug product

Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135

D-1344-2019

April 09, 2019

Class I

Product summary

Firm
SELECT DISTRIBUTIONS LLC
Event
Event 82594
Status
Terminated
Classification
Class I
Quantity
60 boxes
Official record key
drug-enforcement:D-1344-2019

Official wording

Reason: Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil

Code information: All lots

Distribution pattern: MI, OH

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil