Ultra-Sten and D-Zine Supplement Recall [US]


US FlagUS/Silver Spring: Ultra-Sten and D-Zine Supplement Recall [US]Hardcore Formulations recalls all current batch/lots of Ultra-Sten and D-Zine Dietary Supplements due to suspected presence of Anabolic Steroids and consequential risk of a wide range of life-affecting injuries and/or conditions, all serious health hazards. FDA: http://ht.ly/g4Ee30dtRDE

Direct link: https://www.fda.gov/Safety/Recalls/ucm565827.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Supplements are subject to this recall:

  • D-Zine Capsules, sold as dietary supplements for body-building and packaged in 90-count bottles, with a UPC/barcode of 7-48252-86193-1. The Ultra-Sten Supplements were distributed US nationwide to retailers from August 2014 to May 2017 and all batch/lots are affected by this recall.
  • Ultra-Sten Capsules, sold as dietary supplements for body-building and packaged in 90-count bottles, with a UPC/barcode of 7-48252-68763-0. The Ultra-Sten Supplements were also distributed US nationwide to retailers from August 2014 to May 2017 and all batch/lots are affected by this recall.

According to the FDA, Hardcore Formulations has recalled all lots and expiration dates of Ultra-Sten and D-Zine Supplements. These products are labeled to contain Methylstenbolone (in the case of the Ultra-Sten product) and Dymethazine (in the case of the D-Zine product), both of 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.

The FDA reports that consumption of substances containing derivatives of Anabolic Steroids may cause serious liver injury as well as other adverse long-term and/or long-lasting health consequences. These include: 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.

In addition, 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 products.

If you believe you have purchased or have in your possession any of the recalled Ultra-Sten and D-Zine Dietary Supplements, please do not consume them directly nor use them as an ingredient in another preparation. Instead, return the Supplements to the store where you purchased it for a full refund.

==> Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect the drinking water supply and the ecosystem. Do not throw these products into your household garbage or down the drain. Instead, either return them to Hardcore Formulations or your local pharmacy for proper disposal.

If you have any questions about this recall, please contact the company at 1-855-773-6826 from 9:00 AM to 5:00 PM Central Time or e-mail at sales@hardcoreformulations.com.

==> To see other recalls and notifications caused by suspected contaminated or adulterated Dietary or Nutritional Supplements, please search for “supplement” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Anabolic Steroid contamination, please search for “steroid” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 8923-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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