Drug 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
D-0985-2015
Product summary
- Event
- Event 70317
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,479 bottles
- Official record key
drug-enforcement:D-0985-2015
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: US Nationwide and Singapore
Derived failure modes
-
Unknown
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.