Food, drugs, devices › Mira Health Products Ltd.
Drug recall: B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Hea
Mira Health Products Ltd. (Farmingdale, NY) initiated this drug recall on 22 Jul 2013; FDA lists 3 product records under event 65772, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 18% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 15 Sep 2014. Initiation: voluntary: firm initiated. Mira Health Products Ltd. has 3 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mira Health Products Ltd., Farmingdale, NY.
Reason for recall
"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"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1149-2014 | 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 | unknown | Class I | Terminated | 12 Mar 2014 |
| D-1150-2014 | 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. | 11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown) | Class I | Terminated | 12 Mar 2014 |
| D-1151-2014 | METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL | 5,555 bottles | Class I | Terminated | 12 Mar 2014 |
Context
Other enforcement events for Mira Health Products Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Sep 2013 | Nature Science Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags. | Food | Class II | 79 |
| 23 Jul 2013 | Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle). | Food | Class II | 1 |
All 3 events for Mira Health Products Ltd.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.