FDA recall D-1151-2014

Mira Health Products Ltd. · Class I · 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

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-07-22
Report date
2014-03-12
Termination date
2014-09-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Farmingdale, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1151-2014