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Unique Pharmaceuticals, Ltd. – A Voluntary Nationwide Recall of all Sterile Compounded Preparations Have Been Recalled

Unique Pharmaceuticals, Ltd. – A Voluntary Nationwide Recall of all Sterile Compounded Preparations Have Been Recalled

Unique Pharmaceuticals, Ltd., has announced a voluntary nationwide recall of all sterile drug preparations associated with the outsourcing facility and that have not reached the expiration date listed on the products. Unique is initiating the recall due to FDA’s concerns associated with Unique’s compounding facilities and compounding processes. The FDA contends they present a lack of sterility assurance observed during recent FDA inspections.

The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products.

When sterile products are compromised, patients are at risk for serious and possible life-threatening infections. Unique has received no reports of injury or illness associated with the use of its sterile preparations. Patient safety is Unique’s highest priority, and Unique has proceeded with this voluntary action out of an act of caution.

The recall includes all sterile compounded preparations that Unique has supplied to its customers within expiry dates. Non-sterile preparations are not affected by this recall. The affected products were distributed in syringes, vials, and bags.

The preparations covered under this recall were distributed nationwide. Health care providers should stop using all lots of sterile products prepared by Unique until further notice and return unexpired products to the Company.

  • Unique will be contacting customers by phone, fax, mail, or personal visits informing them to return the products to the Company.
  • Consumers or Health Care Providers with questions regarding this recall may contact Unique Pharmaceuticals via telephone at 888-339-0874, from the hours of 9 a.m. to 5 p.m. CST Central Time, Monday through Friday. They can also be contacted using the following e-mail address: recall@upisolutions.com
  • 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
  • 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.

The Parrish Law Firm Defective Drug Attorney works with northern Virginia citizens who have suffered from defective drugs and are looking for fair compensation for their suffering. Contact us today for a free case consultation, or call us at 703-906-4229.

A representative of the Parrish Law Firm, PLLC researched and wrote this article with Mr. Parrish’s consent. If you have any questions regarding the legal implications of what you have just read, please send us your question by clicking here so we can have our attorney review it.

Contamination Found at Ameridose

The Food and Drug Administration has found various potential sources of contamination at a drug-making facility that was founded by the same company as the pharmacy that has been linked to the meningitis outbreak, reports WLFI.com.

Ameridose, a Massachusetts-based company that manufactures injectable drugs, has been undergoing a month-long inspection of its facilities. Inspectors say they found numerous contamination issues ranging from manufacturing to sterility to quality control.

Leaky ceilings, insects, and even birds were found within the facility in an area where drugs were manufactured. Leaks and cracks in the ceiling were found in a room that had “orange, brown, and green” residue on the sterilization equipment. FDA inspectors also claimed that there were at least 53 incidents of bacterial contamination during testing of drug stock solution that remained overlooked.

Ameridose shut down in October for inspection after a meningitis outbreak from its sister company caused 32 deaths. The company also agreed to recall all of its products, though no Ameridose drugs have been linked to infection. On Monday, the company stated that it would address the issues brought up by the FDA and emphasizes its clean record over the past six years.

Source:

  • http://www.wlfi.com/dpp/on_the_money/recalls/FDA-finds-contamination-issues-at-Ameridose_77973681

FDA Rejects Mandatory Special Training To Prescribe Painkillers

The U.S. Food and Drug Administration (FDA) has reported that doctors will not need special training before they can prescribe long-term narcotic painkillers to their patients that can lead to addiction, a ruling that goes against an expert panel’s recommendation, reports The New York Times.

However, the FDA did state companies that make drugs such as methadone, OxyContin and fentanyl will be required to pay for voluntary programs that teach physicians how best to utilize them.

The decision comes after years of discussion and deliberation by the FDA as to how best to approach increasingly wide spread prescription painkiller abuse in the United States. Back in 2010, an outside expert panel created by the FDA strongly rejected voluntary doctor training, claiming that training needed to be mandatory to help lower the rates of strong painkiller misuse, and to make sure that patients received the correct treatment using them.

In the last ten years, deaths related to the abuse of prescription painkillers have reached epidemic proportions, and while the Obama administration has voiced support for mandatory doctor training, they have not yet drafted any legislation that supports it.

Meanwhile, doctor groups like the American Medical Association have rejected the concept of mandatory training programs because of fears that it could decrease the number of doctors that could treat patients suffering from pain.

Long-term use of prescription painkillers may also be linked to other problems other than addiction, like sleep apnea, increased falls and fractures in people over the age of 70, and low hormone production.

Parrish Law Firm, PLLC, based in northern Virginia, fights for those who have suffered from defective drugs. We have dedicated, professional defective drug attorneys who will fight for your fair compensation. Contact us today for a free case consultation, or call us at 703-906-4229.

Humira Known to Cause Life-Threatening Fungal Infection

Humira is a prescription medicine made to treat arthritis. However, the manufacturing company, Abbott, failed to disclose the risk that it may cause a life-threatening fungal infection. The company is believed to have known this as far back as 2008, even before warning physicians about its use. Since Humira was released in 2003, many people may be at risk. Numerous lawsuits have already been filed. Other severe side effects include sever nerve damage and lymphoma.

$212 Million Botox Verdict Thrown Out After Lawyer Uses Hand Gesture

A $212 million verdict against a Botox company has been ruled unfair after Richmond U.S. District Judge Robert Payne used video captured by a courtroom security camera to watch the plaintiff’s lawyer during his closing arguments, reports valawyersweekly.com.

Payne has ordered a new trial after vacating the 2011 jury verdict.

Payne, during analysis of the video, found that the plaintiff’s lawyer used hand gestures to reference a box in relation to an official FDA “black box warning” regarding the negative impacts of Botox side effects.

However, the lawyer had previously promised not to reference the FDA’s warning based on agreed-upon jury instructions.

Payne ruled on Friday, June 1st, that the lawyers hand gestures in complement of his argument made for a trial that was unfair.

Virginia’s law capping punitive damages reduced the $212 million verdict to $12.35 million.

The trial revolved around a man from the Fredericksburg-area who suffered severe nerve damage after receiving Botox treatment for a tremor condition.

If you have suffered at the hands of medical malpractice or defective drugs in Northern Virginia, you need the diligent lawyers at Parrish Law Firm, PLLC to help you recover financially from your pain. Please contact us today for a free case consultation, or call us today at 703-906-4229.

Diabetes Drug Actos Doubles Risk Of Cancer With Use Over Two Years

Researchers have found that taking the diabetes drug Actos (generically known as pioglitazone), produced by Takeda Pharmaceuticals, for more than a 2-year time span doubles one’s risk of developing bladder cancer, though the absolute risk remains low, reports Reuters.

Canadian researchers conducted the study by looking at records of greater than 115,000 British patients who were newly administered the diabetes drugs from 1988 to 2009.

They discovered that the use of Actos for longer than two years was linked to 88 extra cases of bladder cancer per 100,000 person years. For patients who had taken greater than 28,000 mg (milligrams), this number increased to 137 extra cases of bladder cancer.

The British Medical Journal published the study online.

Last year, U.S. and European regulators warned the public of the possible increased bladder cancer risk, but decided to keep Actos available. The sales of the drug dropped with the warnings.

Takeda, the drugs’ producer, says that it is in no doubt of the positives of Actos to treat diabetes and continues to scrutinize the safety of its medications.

Actos is in the same drug class as GlaxoSmithKline’s Avandia, a drug that has been associated with certain heart complications.

If you have been negatively impacted by a defective drug, please contact the lawyers at Parrish Law Firm, PLLC who can help you get the compensation that you deserve. Call us now at 703-906-4229, or contact us via email for a free case consultation.

Is Your Virginia Doctor Buying Medicine From An Unapproved Source?

The US Food and Drug Administration (FDA) has cautioned doctors from across multiple US states to stop buying medicine from unlicensed or foreign suppliers with illegal prescription drugs, reports the Medscape Medical News.

Medical practices from 12 states who have reportedly bought illegal medication from such sources have received letters from the FDA, who urge them to purchase medication either directly from the manufacturer, or licensed US wholesale distributors whose licenses can be verified via the FDA’s website.

“These medical practices are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous,” writes the FDA in an online statement this week.

“The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering such offers,” the FDA continues.

If you suspect criminal activity, please contact the FDA’s Office of Criminal Investigations (OCI) at 1-800-551-3989 or visit the OCI Web site.

If you think you have been affected by defective drugs, please contact us today. Call us at 703-906-4229.

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