Ultra-Sten and D-Zine Capsules by Hardcore Formulations: Recall - Contains Anabolic Steroids

[Posted 07/06/2017]

AUDIENCE: Consumer

ISSUE: Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall. This recall applies to all lot numbers and expiration dates of these products.

Consumption of products containing derivatives of anabolic steroids may cause serious liver injury and other adverse health consequences, including kidney injury, increased risk of heart attack and stroke, decreased high-density lipoprotein (HDL) cholesterol levels, elevated blood pressure, aggressive behavior, male infertility, virilization in women (e.g., menstrual irregularities, deeper voice, increased body hair, baldness, etc.), and enlarged breasts and shrinkage of the testes in men. Patients with underlying cardiac, hepatic, or prostate conditions may be at higher risk for adverse reactions than otherwise healthy users.

BACKGROUND: Ultra-Sten and D-Zine capsules are marketed as dietary supplements for body-building and are packaged  in 90-count bottles, with the bar code 7-48252-68763-0 (Ultra-Sten); 7-48252-86193-1 (D-Zine) and sold through retailers nationwide in the USA. Ultra-Sten and D-Zine capsules were distributed nationwide in the USA to retailers from August 2014 to May 2017.

RECOMMENDATION: Hardcore Formulations is notifying its retailers by a formal recall notification letter and is arranging for a return of all recalled products. Consumers who have Ultra-Sten and D-Zine products should stop using them, return them to their place of purchase or discard in accordance with state and local ordinances for disposal of drug products.

Consumers with questions regarding this recall can contact Hardcore Formulations by phone at 1-855-773-6826 or by email sales@hardcoreformulations.com on Monday through Friday from 9 am to 5 pm Central Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/29/2017 - Press Release - Hardcore Formulations]