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Recall Observatory FDA recall evidence

Drug product

Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.

D-0633-2020

November 13, 2019

Class I

Product summary

Firm
Natures Rx
Event
Event 84279
Status
Terminated
Classification
Class I
Quantity
2,800 capsules
Official record key
drug-enforcement:D-0633-2020

Official wording

Reason: Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

Code information: Lot # 01251ZX1, exp. date 11/2022 UPC: 610877392698

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.