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Recall Observatory FDA recall evidence

Drug product

MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.

D-0314-2015

November 14, 2014

Class II

Product summary

Firm
Chaotic Labz
Event
Event 69779
Status
Terminated
Classification
Class II
Quantity
990 bottles
Official record key
drug-enforcement:D-0314-2015

Official wording

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

Code information: Lot#: CLM061114, Exp 06/16

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.