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Recall Observatory FDA recall evidence

Drug product

Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL

D-337-2013

December 17, 2012

Class I

Product summary

Firm
Performance Plus Marketing, Inc.
Event
Event 63916
Status
Terminated
Classification
Class I
Quantity
70,000 capsules.
Official record key
drug-enforcement:D-337-2013

Official wording

Reason: Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Code information: Lot# 01MJS0712, Exp 07/15.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs