The Recall Desk
CriticalFDA (Drugs)·D-1150-2014·Announced 2014-03-12

Mira Health Recalls Super-DMZ Rx 2.0 Capsules for Unapproved Steroid Ingredient

Mira Health Products Ltd. is recalling Super-DMZ Rx 2.0 Capsules because the product contains an unapproved steroid ingredient and was marketed without FDA approval.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Mira Health Products Ltd. is recalling Super-DMZ Rx 2.0 Capsules, a dietary supplement marketed for lean muscle mass, hardness, and strength. The product is sold in 60-count bottles and was manufactured for Blackstone Labs in Boca Raton, Florida.

The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, which makes it an unapproved new drug.

Approximately 11,200 bottles were distributed nationwide. Affected lot numbers include M55Q (A) with an expiration date of 04/2016, M55Q (2) with an expiration date of 05/16, and E07Q with an unknown expiration date. Consumers should stop using the product and contact the manufacturer for further instructions.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Mira Health Products Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →