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Recall Observatory FDA recall evidence

Drug product

Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351

D-327-2013

August 23, 2012

Class I

Product summary

Firm
Evol Nutrition
Event
Event 63232
Status
Terminated
Classification
Class I
Quantity
1000 blister packs (total both products)
Official record key
drug-enforcement:D-327-2013

Official wording

Reason: Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.

Code information: All lots, no Expiry

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.