FDA recall D-1150-2014

Mira Health Products Ltd. · Class I · drug

Product

Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.

Reason for recall

Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, 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-1150-2014