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Recall Observatory FDA recall evidence

Drug product

METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL

D-1151-2014

July 22, 2013

Class I

Product summary

Firm
Mira Health Products Ltd.
Event
Event 65772
Status
Terminated
Classification
Class I
Quantity
5,555 bottles
Official record key
drug-enforcement:D-1151-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug

Code information: lot number: L54Q

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug