The Recall Desk
CriticalFDA (Drugs)·D-1149-2014·Announced 2014-03-12

B-50 Capsules Recalled for Containing Unapproved Steroid Ingredients

Mira Health Products Ltd. is recalling B-50 capsules because they contain unapproved steroid ingredients, making them unapproved new drugs.

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 B-50 capsules, marketed under the brand Healthy Life Chemistry by Purity First. The product is packaged in 100-count bottles and was manufactured for Purity First Health Products, Inc. The recall covers specific lot numbers C02R and F03Q, which were distributed nationwide.

The FDA issued this recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing revealed that the capsules contain methasterone and dimethazine. These are steroid and steroid-like drug ingredients, which classifies the product as an unapproved new drug.

Consumers who have purchased these specific lot numbers should stop using the product immediately. They should return the product to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735

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 numbers: C02R and F03Q

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 →