D-0988-2015 Class I Terminated
FDA drug recall D-0988-2015 was initiated by Anabolic Science Labs, LLC on December 12, 2014 and is designated Class I. 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… The recall status is terminated (terminated February 8, 2017). Affected quantity: 12,166 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2015
- Initiation Date
- December 12, 2014
- Termination Date
- February 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,166 bottles
Product Description
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 Pattern
US Nationwide and Singapore
Code Information
All lots