The Recall Desk
SevereFDA (Drugs)·D-1151-2014·Announced 2014-03-12

Mira Health Recalls Unapproved Metha-Drol Extreme Dietary Supplement

Mira Health Products Ltd. is recalling 5,555 bottles of Metha-Drol Extreme capsules because the product contains an unapproved steroid ingredient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

Mira Health Products Ltd. is recalling 5,555 bottles of Metha-Drol Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement. The product was manufactured for Blackstone Labs in Boca Raton, Florida, and distributed nationwide. The specific lot number is L54Q.

The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA determined that the product contains dimethazine, which is a steroid and/or steroid-like drug ingredient. This makes the product an unapproved new drug.

Consumers who purchased this product should stop using it immediately. The source text does not specify a return address or refund policy, but consumers should contact the recalling firm or the FDA for further instructions on disposal or return.

The recalled product

Product
METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
Affected units
5,555

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 (1)

  • lot number: L54Q

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 →