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Recall Observatory FDA recall evidence

Drug product

MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA

D-0472-2017

November 30, 2016

Class I

Product summary

Firm
MS Bionic
Event
Event 75753
Status
Terminated
Classification
Class I
Quantity
100 bottles
Official record key
drug-enforcement:D-0472-2017

Official wording

Reason: Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)

Code information: All Lots exp. date 12/2019

Distribution pattern: CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)