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Recall Observatory FDA recall evidence

Drug product

PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC

D-378-2014

August 14, 2013

Class I

Product summary

Firm
Fabscout Entertainment, Inc
Event
Event 66043
Status
Terminated
Classification
Class I
Quantity
18 blister packs of one capsule each
Official record key
drug-enforcement:D-378-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil

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: product found to contain undeclared sildenafil and tadalafil