FDA recall D-0990-2015

Anabolic Science Labs, LLC · Class I · 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

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.

Distribution

US Nationwide and Singapore

Key facts

Status: Terminated
Initiation date: 2014-12-12
Report date: 2015-05-13
Termination date: 2017-02-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Winter Park, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0990-2015