A consent decree of permanent injunction against Medistat U.S. District Judge William H. Steele barred Medistat RX LLC, its owners and pharmacist-in charge, from making, holding, or distributing drugs until it complies with federal law. The Alabama Judge signed off on a consent decree of permanent injunction against Medistat on July 5, 2017. The company is accused by the U.S. Food and Drug Administration (FDA) of failing to remedy microbial contamination in its sterile areas, according to Law360.
The problem was that Medistat manufactured and distributed allegedly sterile drugs that were adulterated and may have been contaminated, as the drugs were made in unsanitary condition. Medistat continued to manufacture and distribute unapproved and misbranded drugs with labeling that did not contain proper directions for use. Despite assurances that these issues had been addressed, follow-up inspections revealed Medistat did not take sufficient corrective action.
In June, the FDA posted warning letters to Hardcore Formulations along with other suppliers, for illegally marketing products labeled as containing steroid and steroid-like substances and promoted to increase muscle mass and strength. Hardcore Formulations is now voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules.
These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine) and are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids, render them “unapproved drugs for which safety and efficacy have not been established and are therefore subject to recall,” according the FDA website.
Ultra-Sten and D-Zine capsules are promoted as dietary supplements for bodybuilding and are sold through retailers nationwide in the United States. The voluntary recall involving these products were distributed nationwide from August 2014 to May 2017.
Recall Notification Letter
Hardcore Formulations is alerting its retailers by a formal recall notification letter and is arranging for a return of all affected products. Consumers who have Ultra-Sten and D-Zine products are advised to stop using them and return them to the place of purchase or discard them in accordance with local ordinances for disposal of drug products.
National law firm Parker Waichman LLP has extensive and successful experience representing clients in all types of litigation. Attorneys at the firm are available to answer any legal questions for individuals seeking to file a potential lawsuit.
What are Anabolic Steroids?
Anabolic steroids are synthetic substances similar to the male hormone testosterone. Physicians frequently prescribe them to treat problems such as delayed puberty, and other problems that may cause the body to make very low amounts of the male hormone. Steroids make muscles bigger and stronger. Steroid hormones include testosterone, estrogen, and cortisol. In the United States, anabolic steroids require a prescription, according to WebMD.
Potential Hazards of Anabolic Steroids
According to the FDA, consumption of products that contain derivatives of anabolic steroids may lead to serious liver injuries as well as other health consequences. These adverse side effects include kidney injury, increased risk of heart attack and stroke, decreased high-density lipoprotein (HDL) cholesterol levels, elevated blood pressure, aggressive behavior, and male infertility. There may also be enlarged breasts and shrinkage of the testes.
In women, there may be menstrual irregularities, deeper voice, increased body, hair, and baldness. Consumers with underlying cardiac, liver, or prostate conditions may be at an increased risk for adverse reactions than otherwise healthy consumers.
History of Violations
In September 2014, FDA inspections showed that aseptic (free of bacteria) processing areas were deficient regarding the system for monitoring environmental conditions. In addition, procedures meant to prevent microbiological contamination of drug products that were meant to be sterile, did not include validation of the sterilization process.
In September 2015, FDA inspections revealed a failure to adequately address issues that had previously been found. Numerous organisms including gram negative bacteria, yeast, and mold were identified during the prior ten months. Certain batches of drugs were still released after failing sterility tests from the laboratory.
Gram Negative Bacteria
Gram negative bacteria can cause infections including pneumonia, bloodstream infection, wound or surgical site infections, and meningitis in healthcare settings. This type of bacteria is resistant to multiple drugs and is increasing resistant to many available antibiotics, according to the Centers for Disease Control and Prevention (CDC).
Illegal Anabolic Steroids
Some adults and teens use illegal anabolic steroids to get bigger muscles, lower body fat, and increase strength. The dose of illegal anabolic steroids is 10 to 100 times higher than the dose a doctor prescribes for medical issues. People often use more than one of these illegal drugs at the same time, called “stacking.” Or they may take the drugs in a cycle from no drug to a high dose over weeks to months, called “pyramiding,” WebMD notes.
Need Legal Help Regarding Hardcore Formulations
If you or someone you know has been affected by a recalled product, you may have valuable legal rights. Parker Waichman law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).