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Recall Observatory FDA recall evidence

Drug product

PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789

D-0990-2015

December 12, 2014

Class I

Product summary

Firm
Anabolic Science Labs, LLC
Event
Event 70317
Status
Terminated
Classification
Class I
Quantity
22,353 bottles
Official record key
drug-enforcement:D-0990-2015

Official wording

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Code information: All lots

Distribution pattern: US Nationwide and Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.