FDA Recall D-1150-2014

Mira Health Products Ltd. · Farmingdale, NY

Class I — life-threatening Terminated 420 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: lot numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16, 3)E07Q Exp unknown

Quantity: 11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown)

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

Recall record

Recall number: D-1150-2014
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide
Recall initiated: 2013-07-22
Classified by FDA Center: 2014-03-05
FDA published: 2014-03-12
Terminated: 2014-09-15
Recalling firm: Mira Health Products Ltd.
Firm location: Farmingdale, NY

‹ All recalls