Mira Health Products Ltd.: Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug; 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; Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingred

Agency Publication Date: March 5, 2014

Affected Products

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

Lot numbers: C02R and F03Q

Lot Numbers:

numbers

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

Lot Numbers:

numbers

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

lot number: L54Q

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65772

Status: Resolved

Manufacturer: Mira Health Products Ltd.

Manufactured In: United States

Units Affected: 3 products (unknown; 11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown); 5,555 bottles)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot numbers: C02R and F03Q

Lot Numbers:

numbers

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

Lot Numbers:

numbers

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

lot number: L54Q

Lot Numbers:

number