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Recall Observatory FDA recall evidence

Drug product

SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

D-0455-2024

March 19, 2024

Class I

Product summary

Firm
Pyramids Wholesale Inc.
Event
Event 94265
Status
Ongoing
Classification
Class I
Quantity
7 pieces
Official record key
drug-enforcement:D-0455-2024

Official wording

Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Code information: All lots

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.