More Compounding Issues From Ameridose, Notes Waxahachie Personal Injury Attorney | Law Firm Newswire

More Compounding Issues From Ameridose, Notes Waxahachie Personal Injury Attorney

Waxahachie, TX (Law Firm Newswire) December 6, 2012 - Disturbing safety issues, including insects and corrosion were found at a drug plant.

Federal inspectors looking for safety and quality issues at a drug-manufacturing facility run by a company currently being investigated for a deadly outbreak of meningitis found numerous issues, including insects and corrosion.

"Individuals depend on drug manufacturers and compounders to observe all precautions and quality measures to ensure the safety and health of the end users is not threatened," stated John Hale, Waxahachie personal injury attorney.

The U.S. Food and Drug Administration (FDA) released a report about the Massachusetts-based plant run by Ameridose, which has stated that it is working on a response to the FDA.

Steroids tainted with a fungus are the cause of at least 32 deaths and almost 430 cases of fungal meningitis. The injectable steroids were made at New England Compounding Center, a compounding pharmacy, now closed, run by Ameridose. Additional plants managed by Ameridose are being investigated.

Ameridose has received in excess of $800,000 in drug orders from various federal agencies since 2007, including some for the Department of Defense and Department of Veteran Affairs. The FDA licenses and regulates Ameridose's drug-manufacturing facility.

The report by the FDA included 33 complaints about Ameridose products that caused a response different from the stated purpose or were blatantly ineffective. The drugs, including Ephedrine, Fentanyl and Oxycontin were not tested for their potency prior to public distribution. The complaints included issues of fetal distress, post-partum hemorrhaging, and shortness of breath, but Ameridose reportedly did not follow up.

In addition to not testing for potency, the FDA inspectors report that Ameridose typically did not appear to test final units of drugs for either sterility or the presence of contaminants. In more than 50 cases where there was observable drug contamination, Ameridose did not investigate it, stated the report. Also, investigators found birds and insects within just a few feet of products that are supposed to stay sterile, and found inadequate contamination safeguards, including no sterile gowns, gloves and glasses.

The FDA report was comprised of "inspectional observations" and is not a final determination by the agency.

John Hale is a Waxahachie personal injury lawyer and Ellis County personal injury lawyer helping injury victims near Dallas, Texas. Learn more at The Hale Law Firm

The Hale Law Firm
100 Executive Court, Suite 3
Waxahachie, TX 75165
Call: 888.425.3911

View Larger Map

  • Texan Government and Legal Professionals Offer Tips for Safe and Happy Driving This Holiday Season
    Year after year, Texas leads the nation in traffic fatalities due to drunk driving. Add to that the still-growing spike in fatal crashes due to the energy boom, and Texans have good reason to think carefully about staying safe on the road this holiday season. Auto accidents can be financially, emotionally and physically devastating, especially during the holidays. Fortunately, it is easy to reduce the risk of being involved in a crash. Stay off the road after 1:00 a.m. Most drunk driving accidents occur between 1:00 a.m. and 3:00 a.m. Even if most people drive sober, inevitably, some will not. […]
  • Stunning Breakthrough Offers Hope for Paralyzed Spinal Cord Injury Patients
    An electrical stimulation implant has helped four paralyzed men regain the ability to move their legs.  The device, called an epidural spine stimulator, was implanted in the men as part of a study undertaken by the University of California, Los Angeles (UCLA) and the University of Louisville. One of the patients in the study, Kent Stephenson, is from Mount Pleasant, Texas. At 21, he was involved in a motocross accident that left him without sensation or motor control from the chest down. Today, he can move his legs, stand on his own and distinguish between types of touch. In addition, […]
  • Expert Links Football Players’ Concussions to Behavioral Problems, Slams NFL Settlement Deal
    A brain injury expert from Boston University is speaking out for players he feels have been unfairly excluded from a settlement deal in the class action lawsuit against the NFL over the health effects of play-related brain injury. Robert Stern filed an affidavit with the court and then took his story to the press, telling The Associated Press (AP) that the compensation in the settlement may be going to the wrong people. Stern told AP reporters that behavioral problems, including domestic violence, drug addiction and suicide, can all be caused by chronic traumatic encephalopathy — also known as CTE — […]

Tags: , , , , ,

Get headlines from Law Firm Newswire sent right to your inbox.

* indicates required