FDA Recall D-0990-2015
Anabolic Science Labs, LLC · Winter Park, FL
Class I — life-threatening Terminated 789 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0990-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- US Nationwide and Singapore
- Recall initiated
- 2014-12-12
- Classified by FDA Center
- 2015-05-05
- FDA published
- 2015-05-13
- Terminated
- 2017-02-08
- Recalling firm
- Anabolic Science Labs, LLC
- Firm location
- Winter Park, FL