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Recall Observatory FDA recall evidence

Drug product

FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM

D-0960-2016

December 11, 2015

Class I

Product summary

Firm
Reesna, Inc
Event
Event 72830
Status
Terminated
Classification
Class I
Quantity
7,250 capsules
Official record key
drug-enforcement:D-0960-2016

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.

Code information: Exp. 12/18

Distribution pattern: Nationwide and United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.