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Recall Observatory FDA recall evidence

Drug product

7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

D-0987-2015

December 12, 2014

Class I

Product summary

Firm
Anabolic Science Labs, LLC
Event
Event 70317
Status
Terminated
Classification
Class I
Quantity
3,808 bottles
Official record key
drug-enforcement:D-0987-2015

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

    reason.no_named_rule · v1.0.0

    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.