PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclo...
FDA Recall #D-0990-2015 — Class I — December 12, 2014
Product Description
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
Reason for Recall
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.
Recalling Firm
Anabolic Science Labs, LLC — Winter Park, FL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
22,353 bottles
Distribution
US Nationwide and Singapore
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated