FDA recall D-0988-2015

Product

ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 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-0988-2015