PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: March 12, 2014 Initiated: July 22, 2013 #D-1150-2014

Product Description

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

Details

Recalling Firm
Mira Health Products Ltd.
Units Affected
11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown)
Distribution
Nationwide
Location
Farmingdale, NY

Frequently Asked Questions

What product was recalled?
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.. Recalled by Mira Health Products Ltd.. Units affected: 11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown).
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on March 12, 2014. Severity: Critical. Recall number: D-1150-2014.