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Recall Observatory FDA recall evidence

Drug product

72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL

D-377-2014

August 14, 2013

Class I

Product summary

Firm
Fabscout Entertainment, Inc
Event
Event 66043
Status
Terminated
Classification
Class I
Quantity
578 blister packs of 1 capsule each
Official record key
drug-enforcement:D-377-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil

Code information: All Lots

Distribution pattern: CA, FL and UT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil