FDA recall D-0985-2015

Product

M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, 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-0985-2015