- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Recall Reason DescriptionUnapproved drugs
- Company Name:
- Hardcore Formulations
- Brand Name:
Brand Name(s)Ultra-Sten, D-Zine
- Product Description:
Product DescriptionMarketed as a dietary supplement
San Marcos, TX, 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.
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. To date, Hardcore Formulations has not received any reports of these or any other illnesses or injuries related to Ultra-Sten or D-Zine.
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. This recall applies to all lot numbers and expiration dates of these products. Ultra-Sten and D-Zine capsules were distributed nationwide in the USA to retailers from August 2014 to May 2017.
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 firstname.lastname@example.org 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.